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 Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number was not provided.The reported patient effects of occlusion and stenosis are listed in the supera peripherial stent system instructions for use as potential adverse effects of peripheral percutaneous intervention.A conclusive cause for the reported obstruction/occlusion and stenosis, and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Dates estimated the udi is unknown due to the part/lot number was not provided.The additional patient deaths reported in the article are captured under a separate medwatch report.Literature attachment: article title - comparison of interwoven nitinol and drug-eluting stents for endovascular treatment of femoropopliteal artery diseasena.

Event Description

The aim of this study was to compare the performance of interwoven nitinol stents (supera self-expanding stents) versus non-abbott drug-eluting stents (des) in the endovascular revascularization of the patient with femoropopliteal arterial lesions.Thirty five patient's were treated with supera stents versus twenty seven with des for the duration of two years.Follow ups were conducted at the 2 month and 12 month after the initial procedure.Although there were some complications (in-stent restenosis, stent occlusion, death, target lesion revascularization) over the duration of the study the results did not provide any evidence to favor the use of one stent over the other.Specific patient information is documented as unknown.Details are listed in the attached article, titled "comparison of interwoven nitinol and drug-eluting stents for endovascular treatment of femoropopliteal artery disease" no additional information was provided.

• 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: 18278937
• MDR Text Key: 329886989
• Report Number: 2024168-2023-13553
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male