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); Pseudoaneurysm (2605)

Event Date 11/01/2011

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: dates estimated.The patient deaths and device malfunctions referenced will be filed under separate medwatch report #s.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.A definitive cause for the reported stenosis, occlusion, pseudoaneurysm and amputation and the relationship to the product, if any, cannot be determined.The reported patient effects of stenosis, occlusion, pseudoaneurysm, and amputation are listed in the supera instructions for use as known potential patient effects associated with the use of the device.Based on the information reported through the research article, a definitive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported unexpected medical intervention and hospitalization were likely related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown as the part and lot numbers were not provided.Article title: a midterm analysis of patients who received femoropopliteal helical interwoven nitinol stents.

Event Description

It was reported through a research article identifying supera that may be related to the following: patient death, restenosis, occlusion, pseudoaneurysm, elongation, malposition, amputation, revascularization, and rehospitalization.This article summarizes clinical outcomes of 315 patients that were treated with supera stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "a midterm analysis of patients who received femoropopliteal helical interwoven nitinol stents.".

• 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: 12359528
• MDR Text Key: 267866232
• Report Number: 2024168-2021-07446
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 08/24/2021

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: 08/05/2021
• Initial Date FDA Received: 08/24/2021
• 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; Disability
• Patient Age: 78 YR