MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF- EXPANDING STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number S-50-120-120-P6

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2022

Event Type  malfunction  

Event Description

Tip of the supera stent delivery device broke off inside the sheath after deployment.It was not retained in the patient per reports.Manufacturer response for peripheral stent system, supera (per site reporter).Unknown, will be reported to mfr by lead cath lab tech.

• Brand Name: SUPERA SELF- EXPANDING STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 13900848
• MDR Text Key: 287893740
• Report Number: 13900848
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 1051961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Female