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

Catalog Number UNK SUPERA

Device Problems Stretched (1601); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Estimated dates:(date of event), (date of implant).Udi # - the udi # could not be provided because the part and lot numbers were not reported.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.Based on the reported information, a definitive cause for the reported stent shortening and/or elongation could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Literature attachment: "comparative outcomes of supera interwoven nitinol vs bare nitinol stents for the treatment of femoropopliteal disease: insights from the xlpad registry".The adverse patient effects referenced are being filed under a separate medwatch report #.The vision and absolute stents referenced are filed under separate medwatch report numbers.(b)(6).

Event Description

It was reported through a research article identifying supera, absolute, and vision stents that may be related to the following: death, restenosis, target vessel/limb revascularization, stent fracture, stent elongation, and stent compression.Details are listed in the attached article, titled, "comparative outcomes of supera interwoven nitinol vs bare nitinol stents for the treatment of femoropopliteal disease: insights from the xlpad registry".

Manufacturer Narrative

(b)(4).

• 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: 9763755
• MDR Text Key: 181157313
• Report Number: 2024168-2020-01832
• 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
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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 Age: 65 YR