MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number UNK SUPERA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 03/01/2010

Event Type  Death  

Event Description

It was reported through a research article that 350 patients were treated for endovascular disease in a single center; however, 200 patient's that were confirmed with femoropopliteal peripheral artery disease (pad) were all treated with supera self-expanding stents.This study was conducted to determine the effects of the intravascular ultrasound (ivus) when used adjunctively with nitinol interwoven bare metal stent and 91 patients received adjunctive ivus imaging prior to stent deployment.Deployment conditions were noted as compressed and elongation with some complications listed (total occlusion, dissection, thrombus, recoil, perforation).Follow up outcomes were noted as target lesion reintervention, amputation and mortality.The patients who received ivus had a greater number of nominally deployed stents and lower reintervention rates compared with those who did not received ivus imaging.The ivus and angiography may decrease clinically-driven target lesion reintervention and may increases nominal deployment compared with angiography alone.Specific patient information is documented as unknown.Details are listed in the attached article, titled "ivus improves outcomes with supera stents for the treatment of superficial femoral-popliteal artery disease" no additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effect death is listed in the supera peripheral stent system instructions for use as a potential adverse event.The investigation determined a conclusive cause for the reported death and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.B2, b3, b6, d6: dates estimated.The additional patient effects and malfunctions reported in the article(s) are captured under separate medwatch reports.Attachment: literature titled, ivus improves outcomes with supera stents for the treatment of superficial femoral-popliteal artery diseasena.

• Brand Name: SUPERA
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18278852
• MDR Text Key: 329869992
• Report Number: 2024168-2023-13548
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Sex: Male