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

Model Number S-50-120-120-P6

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

During a bilateral lower extremity angioplasty, there was malfunction of stent, which miss deployed in right superficial femoral artery.Successfully removed through left common femoral artery.

• Brand Name: SUPERA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 13757116
• MDR Text Key: 287118001
• Report Number: 13757116
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 1032261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2022
• Date Report to Manufacturer: 03/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA