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 Stenosis (2263)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

The date of event will be estimated as (b)(6) 2017.The date of implant will be estimated (b)(6) 2015.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 were not provided.The reported patient effect of stenosis is listed in the supera peripheral stent system instructions for use as a known patient effect.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment 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.The udi is unknown because the part number and lot number were not provided.Literature attachment.Article title: endovascular intervention for the treatment of trans-atlantic inter-society consensus (tasc) d femoropopliteal lesions: a systematic review and meta-analysisna.

Event Description

It was reported through a research article identifying that the supera self-expanding stent system (sess) may be related to the following: restenosis, rehospitalization and revascularization.This article summarizes the data of 51 studies with a total of 3,029 patients; however, 28 patients in the brescia study 2015 were treated only with the supera.The brescia study at the two year follow up showed a primary patency rate of 82%, while the secondary patency rate was at 93%.Specific patient information is documented as unknown.Details are listed in the attached article, titled "endovascular intervention for the treatment of trans-atlantic inter-society consensus (tasc) d femoropopliteal lesions: a systematic review and meta-analysis".

• 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: 12379047
• MDR Text Key: 268521771
• Report Number: 2024168-2021-07599
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 08/27/2021
• 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