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

Model Number S-55-120-120-P6

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2021

Event Type  malfunction  

Event Description

Doctor was deploying a stent in the left sfa from the right groin access.The physician in process of deploying stent states stent dislodged.Fda safety report id#: (b)(4).

• Brand Name: ABBOTT SUPERA STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT / ABBOTT VASCULAR
• MDR Report Key: 11343494
• MDR Text Key: 232814788
• Report Number: MW5099457
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-55-120-120-P6
• Device Lot Number: 0030361
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 66 YR