MAUDE Adverse Event Report: SUPERA TRAINS HEPATIC BILIARY SYSTEM EXPANDING NITIONOL STENT

Model Number M789041201206F11

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Pressure Sores (2326); Hypoesthesia, Foot/Leg (2354); Reaction (2414); Ambulation Difficulties (2544); Vascular System (Circulation), Impaired (2572)

Event Date 12/19/2013

Event Type  Injury  

Event Description

A (b)(6) male survivor of ewing's sarcoma that underwent angiogram and stent placement of the affected leg that was intensely radiated when he was undergoing treatments for the cancer.He developed foot drop in 2008 and started having issues with pressure sores under the bottom of the foot.A group of physicians decided that there was decreased blood flow to the foot and to try and improve that he underwent the stent placement procedure.He began to experience lots of pain behind the knee during the procedure and the procedure was suppose to take 1.5 hrs and took 4.The popliteal artery when the physician put the stent in place and the stent was reported to us as being engulfed or absorbed by the artery.Since the procedure, the pt cannot straighten the leg, bare weight, lie down in the bed to sleep, has a knot behind the knee that is hard now extending down into the calf, and heat in the knee.We clearly feel his is having a reaction to this stent.We are continuing to work with the physicians to figure out what is wrong but any feedback or info that you could help us would be appreciated.We hope this feedback will help someone else.

• Brand Name: SUPERA TRAINS HEPATIC BILIARY SYSTEM EXPANDING NITIONOL STENT
• Type of Device: SUPERA TRAINS HEPATIC BILIARY SYSTEM EXPANDING NITIONOL STENT
• MDR Report Key: 3599064
• MDR Text Key: 4188693
• Report Number: MW5033998
• Device Sequence Number: 1
• Product Code: FGE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M789041201206F11
• Device Lot Number: $021670551
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 46 YR
• Patient Weight: 109