MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT VASCULAR SUPERA 6.5X8-X120; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number S-65-080-12-PG

Device Problem Break (1069)

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

Event Date 06/17/2020

Event Type  Injury  

Event Description

The nose cone of the supera stent broke off into the left external iliac artery.Fda safety report id# (b)(4),.

• Brand Name: ABBOTT VASCULAR SUPERA 6.5X8-X120
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA 95054
• MDR Report Key: 10194713
• MDR Text Key: 196609330
• Report Number: MW5095203
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: S-65-080-12-PG
• Device Lot Number: 8121361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 88