FDA Adverse Event Injury Summary report: N

WELLFLEX BILIARY RX STENT SYSTEM

MDR report key: 3922843 · Received July 9, 2014

Report

Report Number: 3005099803-2014-02440
Event Type: Injury
Date Received: July 9, 2014
Report Date: June 19, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: K061231
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GB
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. 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

BOSTON SCIENTIFIC CORPORATION OBTAINED INFORMATION AT THE BRITISH SOCIETY OF GASTROENTEROLOGY ANNUAL MEETING ON (B)(6) 2014 THAT A STUDY PERFORMED AT (B)(6) NOTED PATIENT ISSUES WHEN USING WALLFLEX FULLY COVERED BILIARY STENTS. ACCORDING TO THE COMPLAINANT, THERE WERE HIGHER INCIDENCES OF PANCREATITIS IN PATIENTS IMPLANTED WITH WALLFLEX FULLY COVERED BILIARY STENTS AS COMPARED WITH PATIENTS IMPLANTED WITH WALLFLEX UNCOVERED BILIARY STENTS. IN THE PHYSICIAN¿S ASSESSMENT, THE COVERED NATURE OF THE STENT LED TO AN INCREASED LEVEL OF PANCREATITIS. 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
399423	WELLFLEX BILIARY RX STENT SYSTEM	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	UNK475

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other