MAUDE Adverse Event Report: ABBOTT ABBOTT VASCULAR SUPERA; STENT

Model Number S55150120P6

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

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

Event Date 03/21/2016

Event Type  malfunction  

Event Description

Stent placed in the right popliteal artery and when removing the sheath, the tip of the sheath dislodged and separated from the body of the sheath, resulting in an open procedure to remove the tim from the vessel.

• Brand Name: ABBOTT VASCULAR SUPERA
• Type of Device: STENT
• Manufacturer (Section D): ABBOTT; santa clara CA 95054
• MDR Report Key: 5525716
• MDR Text Key: 41223607
• Report Number: MW5061248
• Device Sequence Number: 1
• Product Code: NIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: S55150120P6
• Device Lot Number: 5112361
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 85