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

Model Number 4.5 X 60 MM 120CM

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2023

Event Type  Injury  

Event Description

Abbott supera stent delivery device was inserted over the wire and was unable to cross the lesion.The device was removed.Cardiologist noticed a piece of the delivery system missing and the stent was off the delivery device.The missing piece was snared and retrieved.

• Brand Name: ABBOTT SUPERA STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 18132063
• MDR Text Key: 328223448
• Report Number: MW5148102
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4.5 X 60 MM 120CM
• Device Catalogue Number: S-45-060-120-P6
• Device Lot Number: 2101962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White