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

Model Number S-55-150-120-P6

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2020

Event Type  malfunction  

Event Description

Doctor deployed the 5.5x150 mm abbott vascular supera stent in the superior femoral artery to popliteal artery.After the stent was deployed the doctor tried to remove the nose cone and it got caught on the stent.The nose cone detached from the device.Doctor then used a 6 fr snare and removed all of the nose cone.

• 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: 10605519
• MDR Text Key: 209142648
• Report Number: 10605519
• 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: 09/16/2020,08/26/2020

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 Operator: Health Professional
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 0030961
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 65