inforMED
MalfunctionIGE

COTTON LEUNG BILIARY

Received Jan 9, 2004

Report 1037905-2004-00005 · MDR key 508914

Device

Generic name

Biliary Stents

Model number

NA

Catalog number

CLBS-10-5

Lot number

UNK

Product problems

  • Explanted
  • Fracture
  • Device, or device fragments remain in patient

Patient

37 YR

  • Nonresorbable materials, unretrieved in body
  • Surgical procedure

Narrative

Description of Event or Problem

THE PHYSICIAN REMOVED MULTIPLE WILSON-COOK COTTON LEUNG BILIARY STENTS IN A STENT EXCHANGE PROCEDURE. THREE MONTHS AFTER STENT PLACEMENT TWO OF THREE STENTS WERE REMOVED SUCCESSFULLY USING A MINISNARE. RESISTANCE WAS ENCOUNTERED WHILE TRYING TO REMOVE THE THIRD STENT FROM THE PT'S DUCT. THIS DIFFICULTY RESULTED IN THE MINISNARE FRACTURING THE DISTAL END OF THE STENT AS IT WAS REMOVED. AN ERCP PROCEDURE REVEALED A FRAGMENT OF THE STENT IN THE PT'S DUCT. AFTER AN UNSUCCESSFUL ATTEMPT TO REMOVE THE FRAGMENT WITH A RETRIEVAL BASKET THE PHYSICIAN DECIDED TO LEAVE THE FRAGMENT IN PLACE WITH CONTINUED STENT EXCHANGES AT THREE MONTH INTERVALS.