MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number S-55-080-120-P6

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2017

Event Type  malfunction  

Event Description

A supera 5.5x80 mm stent was deployed into the patient's superficial femoral artery (sfa).Three (3) more zilver stents were deployed and then small segment of wire visualized on angiogram.It was thought that the nose cone of the supera that had become detached from tip of stent.The stent appeared to be deployed correctly.A snare wire was deployed, the wire and nose cone was captured in the snare and pulled through sheath.The sheath was cut and the wire dragged out.The sheath was exchanged over wire for new 6 ansel sheath.No harm to patient aside from increased radiation time.

• Brand Name: SUPERA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 6680974
• MDR Text Key: 78850923
• Report Number: 6680974
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: S-55-080-120-P6
• Device Catalogue Number: S-55-080-120-P6
• Device Lot Number: 7022361
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR