MAUDE Adverse Event Report: ABBOTT LABORATORIES SUPERA PERIPHERAL STENT 6.5MM X 88MM

Lot Number 02230067

Device Problems Unintended Collision (1429); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Intimal Dissection (1333); Death (1802); Hemorrhage/Bleeding (1888)

Event Date 11/04/2014

Event Type  No Answer Provided  

Event Description

Supera peripheral stent platform was being withdrawn from the right iliac, the platform caught the stent and dislodged the stent into the aortic bifurcation.Peripheral balloon removed uninflated.Unable to cross into the right femoral artery.Attempted to advance the filter wire removal tool to remove the filter wire, unable to advance the filter removal tool, filter wire pulled back to the left femoral artery and removed as one with the sheath.Angiogram performed to the right sfa and large dissection noted with brisk retro peritoneal bleeding.

• Brand Name: SUPERA PERIPHERAL STENT 6.5MM X 88MM
• Type of Device: PERIPHERAL STENT
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park rd.; abbott park IL 60064
• MDR Report Key: 4330405
• MDR Text Key: 5246947
• Report Number: MW5039543
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/31/2015
• Device Lot Number: 02230067
• Other Device ID Number: S-65-080-120-P6
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR