FDA Adverse Event Injury Summary report: N

WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS 6961-6972 INCLUSIVE

MDR report key: 3243638 · Received July 23, 2013

Report

Report Number: 3005099803-2013-07297
Event Type: Injury
Date Received: July 23, 2013
Report Date: June 27, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: K012752
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4) FOR THE REPORTED EVENT OF STENT FAILED TO EXPAND. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS IMPLANTED WITHIN THE COMMON BILE DUCT (CBD) ON AN UNKNOWN DATE, DURING A BILIARY STENT PLACEMENT PROCEDURE. THE STENT WAS PLACED AND SOMETIME POST PROCEDURE, THE PATIENT HAD FEVER AND ABDOMINAL PAIN. A X-RAY WAS TAKEN AND THE PHYSICIAN NOTED THAT THE STENT HAD NOT FULLY EXPANDED. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
343717	WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS 6961-6972 INCLUSIVE	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	UNK384

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention