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

Catalog Number UNK SUPERA 6F

Device Problem Break (1069)

Patient Problems Thrombosis (2100); Claudication (2550)

Event Date 10/13/2019

Event Type  Injury  

Manufacturer Narrative

Event dates estimated.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.The reported patient effects of claudication and thrombosis are listed in the supera instructions for use (ifu) as known potential patient effects of peripheral percutaneous intervention.A definitive cause for the reported claudication and thrombosis, and the relationship to the product, if any, cannot be determined.A definitive cause for the reported stent fractures could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The udi is unknown because the part and lot #s were not provided.Article attachment: title: early supera stent fracture in the femoropopliteal artery.

Event Description

It was reported through a research article identifying a patient that presented with claudication.After pre-dilatation, an unspecified 5x80mm supera self-expanding stent was implanted in the right popliteal artery.12 days later, the patient returned with claudication, thrombus, and stent fractures, which were treated with several balloons.3 days after that, the patient had claudication again, so the patient was sent to bypass surgery and is doing well.No additional information was provided.Details are listed in the attached article, titled "early supera stent fracture in the femoropopliteal artery.".

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Attachment: [cn-028925.Pdf].

• 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: 9916894
• MDR Text Key: 189470511
• Report Number: 2024168-2020-03277
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA 6F
• 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
• Treatment: .014 COMMAND GUIDE WIRE; 6F ANSEL SHEATH; CXI MICROCATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 73 YR