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

Catalog Number UNK SUPERA

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

Patient Problems Ischemia (1942); Occlusion (1984); Pain (1994); Stenosis (2263); Claudication (2550)

Event Date 10/13/2014

Event Type  Injury  

Manufacturer Narrative

Mean age.Majority gender.Event estimated date.The device is not returning for analysis.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional supera device is filed under a separate medwatch report number.Attachment: "stenting of femoropopliteal lesions using interwoven nitinol stents".

Event Description

It was reported through a research article that the 5.5mm and 6.5mm supera stents may be related to claudication, rest pain, tissue loss (non-healing ulcers and gangrene), restenosis, occlusion, re-intervention including laser atherectomy, percutaneous transluminal angioplasty, additional stent placement, and femoropopliteal bypass.Specific patient information is documented as unknown.Details provided in the attached article titled: " "stenting of femoropopliteal lesions using interwoven nitinol stents".

Manufacturer Narrative

D4: the udi# is unknown because the part and lot numbers were not provided.The device was not returned for analysis.The lot history record for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.In this case, there was no reported device malfunction associated with the supera self-expanding stent system (sess).The reported patient effects of worsening claudication, pain, ischemia, restenosis and occlusion are listed in the supera instructions for use as known potential adverse patient effects of peripheral percutaneous intervention.Based on the case information, a conclusive cause for the reported patient effect(s), 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.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10005978
• MDR Text Key: 189834552
• Report Number: 2024168-2020-03957
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 64 YR