MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA STENT 4.5FR X 80; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number S-45-080-120-P6

Device Problem Separation Failure (2547)

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

Event Date 08/06/2019

Event Type  Injury  

Event Description

Physician was implanting a supera stent percutaneously when they felt it release and the cone tip was released into the previous stent and he was unable to dislodge it during angiograms.Physician decided to do a right femoral cutdown and exploration with removal of the stent.All pieces of the stent were removed.

• Brand Name: SUPERA STENT 4.5FR X 80
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 8974721
• MDR Text Key: 156927390
• Report Number: 8974721
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-45-080-120-P6
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 8081661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 20440 DA
• Patient Weight: 64