WALLFLEX¿ BILIARY

Report

Report Number: 3005099803-2011-02670
Event Type: Injury
Date Received: August 4, 2011
Date of Event: June 30, 2011
Report Date: July 13, 2011
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: K083627
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION. (B)(4) THE REPORTED ISSUE OF STENT OCCLUSION. (B)(4) THE REPORTED ISSUE OF STENT MIGRATED. (B)(4) THE REPORTED ISSUE OF STENT DAMAGE. (B)(4) STUDY. A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW IDENTIFIED THAT THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. HOWEVER, THE DEVICE WAS USED AS PER THE (B)(4) STUDY PROTOCOL TO ASSESS THE SAFETY AND PERFORMANCE OF TEMPORARY PLACEMENT OF THE WALLFLEX BILIARY RX FULLY COVERED STENTS AS A TREATMENT OF BILLIARD OBSTRUCTION RESULTING FROM BENIGN BILE DUCT STRICTURES. BASED ON THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION RECEIVED (B)(4), 2011. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED FOR A DISTAL BILIARY STRICTURE ON (B)(6), 2011. THIS PROCEDURE WAS CONDUCTED AS PART OF THE (B)(4) WALLFLEX BILIARY FC BENIGN STRICTURE STUDY. ACCORDING TO THE COMPLAINANT, A CHOLANGIOGRAM PERFORMED ON (B)(6), 2011 REVEALED A DISTAL BILIARY STRICTURE, WHICH HAD BEEN PREVIOUSLY TREATED WITH A PLASTIC STENT AND A SPHINCTEROTOMY. DURING THE STENT PLACEMENT PROCEDURE, THE PLASTIC STENT WAS REMOVED, AND A SPHINCTEROTOMY WAS NOT PERFORMED. ON (B)(6), 2011, 48 DAYS AFTER STENT PLACEMENT, THE PATIENT EXPERIENCED AN EPISODE OF CHOLANGITIS. THE PATIENT RECEIVED MEDICAL TREATMENT AND THE EVENT WAS REPORTED AS RESOLVED ON (B)(6), 2011. ON (B)(6), 2011, 60 DAYS AFTER STENT PLACEMENT, THE PATIENT UNDERWENT ENDOSCOPIC INTERVENTION OF SLUDGE REMOVAL DUE TO STENT OCCLUSION. THE STUDY STENT WAS REMOVED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A (B)(4) COVERED STENT WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED FOR A DISTAL BILIARY STRICTURE ON (B)(6) 2011. THIS PROCEDURE WAS CONDUCTED AS PART OF THE (B)(4) STUDY. ACCORDING TO THE COMPLAINANT, A CHOLANGIOGRAM PERFORMED ON (B)(6) 2011 REVEALED A DISTAL BILIARY STRICTURE, WHICH HAD BEEN PREVIOUSLY TREATED WITH A PLASTIC STENT AND A SPHINCTEROTOMY. DURING THE STENT PLACEMENT PROCEDURE, THE PLASTIC STENT WAS REMOVED, AND A SPHINCTEROTOMY WAS NOT PERFORMED. ON (B)(6) 2011, 48 DAYS AFTER STENT PLACEMENT, THE PATIENT EXPERIENCED AN EPISODE OF CHOLANGITIS. THE PATIENT RECEIVED MEDICAL TREATMENT AND THE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2011. ON (B)(6) 2011, 60 DAYS AFTER STENT PLACEMENT, THE PATIENT UNDERWENT ENDOSCOPIC INTERVENTION OF SLUDGE REMOVAL DUE TO STENT OCCLUSION. THE STUDY STENT WAS REMOVED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2011. DURING THE STUDY STENT REMOVAL, THE STENT WAS NOTED TO HAVE MIGRATED. THE EXACT LOCATION AND DISTANCE OF THE MIGRATION IS CURRENTLY UNKNOWN. ADDITIONALLY, THE STENT WAS ALSO NOTED TO BE KINKED/DEFORMED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED FOR A DISTAL BILIARY STRICTURE ON (B)(6) 2011. THIS PROCEDURE WAS CONDUCTED AS PART OF THE (B)(4) STUDY. ACCORDING TO THE COMPLAINANT, A CHOLANGIOGRAM PERFORMED ON (B)(6), 2011 REVEALED A DISTAL BILIARY STRICTURE, WHICH HAD BEEN PREVIOUSLY TREATED WITH A PLASTIC STENT AND A SPHINCTEROTOMY. DURING THE STENT PLACEMENT PROCEDURE, THE PLASTIC STENT WAS REMOVED, AND A SPHINCTEROTOMY WAS NOT PERFORMED. ON (B)(6) 2011, 48 DAYS AFTER STENT PLACEMENT, THE PATIENT EXPERIENCED AN EPISODE OF CHOLANGITIS. THE PATIENT RECEIVED MEDICAL TREATMENT AND THE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2011. ON (B)(6) 2011, 60 DAYS AFTER STENT PLACEMENT, THE PATIENT UNDERWENT ENDOSCOPIC INTERVENTION OF SLUDGE REMOVAL DUE TO STENT OCCLUSION. THE STUDY STENT WAS REMOVED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2011: DURING THE STUDY STENT REMOVAL, THE STENT WAS NOTED TO HAVE MIGRATED. THE EXACT LOCATION AND DISTANCE OF THE MIGRATION IS CURRENTLY UNKNOWN. ADDITIONALLY, THE STENT WAS ALSO NOTED TO BE KINKED/DEFORMED. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2011: ACCORDING TO THE COMPLAINANT, "STENT WAS FINE WHEN ERCP WAS PERFORMED BUT MIGRATED WHILE CLEANING IT WITH THE BALLOON. SINCE IT WAS TOO FAR OUT, IT WAS REMOVED. CONTROL CHOLANGIOGRAM SHOWED NORMAL BILE DUCT SO NOTHING ELSE WAS DONE. THE FINAL RESULT IS GOOD."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	WALLFLEX¿ BILIARY	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	M00570830	13469789

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention