FDA Adverse Event Injury Summary report: N

WALLSTENT RX BILIARY ENDOPROSTHESIS

MDR report key: 1253116 · Received December 5, 2008

Report

Report Number: 3005099803-2008-06947
Event Type: Injury
Date Received: December 5, 2008
Date of Event: December 28, 2005
Report Date: November 7, 2008
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: FGE
PMA / PMN Number: K012752
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS. IT WAS REPORTED THAT 50 DAYS FOLLOWING PLACEMENT OF A BILIARY WALLSTENT, THE STENT MIGRATED AND WAS REMOVED. THE PATIENT HAD A COVERED BILIARY WALLSTENT PLACED TO MANAGE THE BILIARY STRICTURE. THE PATIENT COMPLAINED OF JAUNDICE POST STENT PLACEMENT AND WAS ASSESSED FOR STENT MIGRATION 50 DAYS FOLLOWING STENT PLACEMENT. THE STENT HAD MIGRATED FROM THE DISTAL CBD (COMMON BILE DUCT) TO THE PROXIMAL CBD. THE STENT WAS REMOVED USING A SNARE AND BALLOON DILATION WITH NO TECHNICAL OR CLINICAL COMPLICATIONS. A BALLOON SWEEP EXTRACTION OF STONES WAS PERFORMED POST STENT REMOVAL. THE EVENT WAS REPORTED TO BE RESOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	WALLSTENT RX BILIARY ENDOPROSTHESIS		FGE	BOSTON SCIENTIFIC CORPORATION	M00569710

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Required Intervention