Relay Pro Thoracic Stent Graft Injury and Death Lawsuit Lawyers

FDA Class I Recall Involves Certain Relay Pro Thoracic Stent Grafts After Reports of Device Release Failure, Emergency Open Surgery, Stroke, Aortic Perforation, and Patient Deaths.

What Parker Waichman LLP Found

• The FDA classified the Relay Pro Thoracic Stent Graft issue as a Class I recall.
• The affected devices include N4 Non-Bare Stent Configuration models, sizes 32 mm and above.
• Reports describe failure of the graft to unclasp from the delivery system during use.
• Reported deaths involved serious complications, including aortic perforation and stroke after conversion to open surgery.
• Patients and families may need a legal investigation to determine whether a recalled device caused or contributed to serious harm.

The U.S. Food and Drug Administration has classified the Relay Pro Thoracic Stent Graft safety issue as a Class I recall. A Class I recall is the FDA’s most serious recall category and is used when a product may cause serious injury or death. This recall involves certain Relay Pro Thoracic Stent Graft System devices used in procedures to repair damaged or weakened areas of the thoracic aorta.

The affected products include Relay Pro Thoracic Stent Graft System, N4, Non-Bare Stent Configuration, sizes 32 mm and above. These devices are associated with Bolton Medical, which is now part of Terumo Aortic. The device is used by vascular surgeons and interventional cardiologists in thoracic endovascular aortic repair procedures.

The safety issue involves reports that the stent graft may be unable to unclasp from the delivery system during use. According to the reported recall information, the problem may occur because the proximal clasp becomes disconnected from the outer control tube. This creates a dangerous situation because the failure may not be recognized until the procedure is already underway.

Once the device is in this stage of the procedure, the implant may not be able to be recaptured. If existing bailout methods fail, the surgical team may be forced to convert the procedure to open surgery. That type of emergency conversion can greatly increase the risks to the patient, especially in an already high-risk vascular procedure.

Why This Recall Matters to Patients and Families

Thoracic stent grafts are used in serious medical situations. Patients who receive these devices may already be facing life-threatening aortic conditions, including aneurysms, dissections, traumatic injuries, or other dangerous weakening of the thoracic aorta. These patients rely on the device to deploy correctly and allow the surgeon to complete the repair safely.

When a stent graft fails to release properly, the surgical team may have limited options. A device that cannot unclasp from the delivery system can delay the procedure, interfere with placement, cause displacement, or force an emergency change in surgical approach. These are not minor complications. They can create immediate danger inside one of the body’s most important blood vessels.

Reported outcomes connected to this issue include patient deaths, aortic perforation, and conversions to open surgery that resulted in fatal strokes. These are the types of complications that may justify a legal investigation into the device design, manufacturing, warnings, training materials, recall timing, and whether physicians and hospitals received adequate notice before using the product.

Families may not know which device was used unless they request records. Operative reports, implant logs, hospital supply records, device stickers, and manufacturer tracking information may identify whether a recalled Relay Pro device was involved.

How the Relay Pro Device Problem May Occur During Surgery

The reported failure involves the stent graft’s release mechanism. In some cases, the graft may not unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. A clinician may recognize the problem when there is a lack of resistance while sliding the apex holder back, combined with failure of the proximal stent to release.

This is especially concerning because the failure may not be obvious before the device is used. A surgical team may only discover the issue after the device is already inside the patient and the procedure has reached a critical point. At that stage, the options may be limited, and the patient may be exposed to serious danger.

Potential complications may include:

• Procedure delay during a high-risk vascular repair
• Stent graft displacement or improper deployment
• Inability to release the device from the delivery system
• Aortic injury or perforation
• Emergency conversion to open surgery
• Stroke, major bleeding, organ damage, or death

A medical device used in the thoracic aorta must function with a high degree of reliability. When the device fails during deployment, the risk is not theoretical. The patient may be under anesthesia, the aorta may already be accessed, and surgeons may need to make rapid decisions to prevent catastrophic harm.

Who May Be Affected by the Recall?

Patients may be affected if they underwent a thoracic endovascular aortic repair procedure involving a Relay Pro Thoracic Stent Graft System, N4, Non-Bare Stent Configuration, size 32 mm or larger. These procedures are often performed by vascular surgeons, cardiothoracic surgeons, or interventional cardiologists.

Patients and families should consider obtaining records if the patient experienced complications during or after a thoracic aortic repair procedure, including emergency open surgery, stroke, aortic rupture, aortic perforation, major bleeding, prolonged hospitalization, neurological injury, or death.

Important records may include:

• Operative report
• Implant record
• Device identification stickers
• Hospital billing records
• Surgeon notes
• ICU records
• Discharge summary
• Imaging reports
• Death certificate, if applicable
• Autopsy report, if one was performed

These records may help determine whether a recalled Relay Pro device was used and whether the complication occurred during device deployment.

Potential Relay Pro Thoracic Stent Graft Lawsuits

A product liability lawsuit involving a recalled thoracic stent graft may focus on whether the device was defectively designed, defectively manufactured, inadequately tested, or sold with insufficient warnings. A legal claim may also examine whether the company acted quickly enough once adverse events were reported.

Potential claims may include defective design, manufacturing defect, failure to warn, negligence, breach of warranty, and wrongful death. The specific claims depend on the facts of the case, the patient’s injuries, the timing of the procedure, the device model and size, and the available medical records.

Compensation in a serious medical device case may include medical bills, lost income, loss of future earning capacity, pain and suffering, disability, loss of quality of life, funeral expenses, and wrongful death damages. In fatal cases, surviving family members may be able to bring claims under the applicable wrongful death law in their state.

These cases require careful investigation because the patient may have had a serious underlying aortic condition before the procedure. The legal question is not simply whether the patient was already ill. The question is whether a device failure caused or contributed to preventable harm, emergency surgery, stroke, aortic injury, or death.

Relay Pro Thoracic Stent Graft Injury Lawsuit FAQs

Can I File a Lawsuit If a Relay Pro Thoracic Stent Graft Failed During Surgery?

You may have a potential claim if a recalled Relay Pro Thoracic Stent Graft failed during surgery and caused serious injury or death. These claims often require a close review of the operative report, implant record, complication timeline, and post-operative medical records. A lawsuit may focus on whether the device failed to release, whether the failure forced emergency open surgery, and whether the complication caused preventable harm.

What Injuries May Be Linked to the Relay Pro Recall?

Reported complications may include aortic perforation, stroke, emergency conversion to open surgery, prolonged procedure time, major bleeding, neurological injury, and death. Patients may also suffer extended hospitalization, rehabilitation needs, loss of independence, and long-term disability. Each case must be reviewed individually because patients receiving thoracic stent grafts often have serious underlying vascular conditions.

How Do I Find Out Whether a Recalled Device Was Used?

The best way to confirm device use is to request hospital records. The implant log, operative report, billing records, device stickers, and supply records may identify the device name, model, size, lot number, and manufacturer. Families should request these records as soon as possible because they may be critical evidence in a product liability case.

What If the Patient Died After the Procedure?

A surviving family may have a wrongful death claim if a recalled device caused or contributed to the death. A legal investigation may examine whether the device failed during deployment, whether the patient had to be converted to open surgery, whether a stroke or aortic injury occurred, and whether the death was connected to the reported device problem.

Why Should Families Act Quickly?

Medical device cases depend heavily on records, timelines, device identification information, and witness accounts. Evidence may become harder to obtain over time. Legal deadlines also vary by state. Families should act quickly to preserve medical records, identify the device, and determine whether the recall may be connected to the injury or death.

Contact Parker Waichman LLP For A Free Case Review

A medical device failure during a thoracic aortic procedure can change a family’s life in seconds. Patients depend on these devices to deploy correctly during high-risk vascular surgery. When a recalled device may have caused emergency open surgery, stroke, aortic perforation, or death, families deserve answers.

Parker Waichman LLP is a national personal injury law firm representing people harmed by dangerous medical devices and defective products. If you or a loved one suffered serious complications after a Relay Pro Thoracic Stent Graft procedure, you may be entitled to compensation.

Call Parker Waichman LLP today for a free consultation at 1-800-YOUR-LAWYER (1-800-968-7529). Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.