WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057

Report

Report Number: 3005099803-2010-04668
Event Type: Injury
Date Received: November 4, 2010
Date of Event: September 8, 2010
Report Date: October 14, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: K083627
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: PATIENT WEIGHT (B)(6), FOREIGN SOURCE: (B)(6), STUDY SOURCE: (B)(4) STUDY.

Additional Manufacturer Narrative · 1

(B)(4) - NON-SURGICAL MEDICAL INTERVENTION REQUIRED; HIGH BILIRUBIN LEVELS. (B)(4) - STENT MIGRATION. FOREIGN SOURCE: (B)(6). STUDY SOURCE: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. 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 BOSTON SCIENTIFIC WALLFLEX BILIARY FC BENIGN STRICTURE STUDY PROTOCOL. THE MOST PROBABLE ROOT CAUSED HAS BEEN LABELED AS AN ANTICIPATED PROCEDURAL COMPLICATION.

Description of Event or Problem · 1

THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04718 REFERS TO THE 8X80 STENT WHICH WAS NOT IMPLANTED, WHILE MANUFACTURER REPORT # 3005099803-2010-04668 REFERS TO THE 10X80 STENT WHICH WAS IMPLANTED FOR A PERIOD OF 7 DAYS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY RX COVERED STENTS WERE USED DURING A BILIARY STENTING PROCEDURE WITHIN THE PROXIMAL PORTION OF THE COMMON BILE DUCT ON (B)(6) 2010. THIS PROCEDURE WAS CONDUCTED AS PART OF THE (B)(4) STUDY. ACCORDING TO THE COMPLAINANT, A CHOLANGIOGRAM PERFORMED ON (B)(6) 2010, REVEALED A PROXIMAL BILIARY STRICTURE, WHICH HAD BEEN PREVIOUSLY TREATED WITH A PLASTIC STENT. DURING THE (B)(6) STENT PLACEMENT PROCEDURE, THE PLASTIC STENT WAS NOT REMOVED, AND A SPHINCTEROTOMY WAS NOT PERFORMED. DUE TO THE RELATIVE SMALL CALIBER OF THE DONOR DUCT, AN 8X80 (B)(4) STUDY STENT WAS CHOSEN AND PLACED ACROSS THE STRICTURE; THIS STENT, HOWEVER, IMMEDIATELY MIGRATED (MOST LIKELY DUE TO THE SMALLER DIAMETER). THIS STENT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN WAS THEN ABLE TO SUCCESSFULLY IMPLANT THE 10X80 WALLFLEX ACROSS THE STRICTURE. ON (B)(6) 2010, THE PATIENT EXPERIENCED NAUSEA AND VOMITING. ADDITIONALLY, AN ERCP WAS CONDUCTED DUE TO A RISE IN BILIRUBIN LEVELS. THE PHYSICIAN NOTICED THAT THE IMPLANTED STENT HAD MIGRATED AS WELL. THE PHYSICIAN SUSPECTS THAT THE MIGRATION WAS DUE TO THE LOCAL ANATOMY, WITH ONLY A RELATIVELY SHORT PART OF THE STENT ABOVE THE STENOSIS. THIS STENT WAS SUCCESSFULLY AND UNEVENTFULLY REMOVED USING FORCEPS, AND ANOTHER STENT WAS IMPLANTED. THE NAUSEA AND VOMITING WERE REPORTED TO HAVE BEEN "RESOLVED" ON (B)(6) 2010. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. BECAUSE THE STENT WAS REMOVED, THE PATIENT IS NO LONGER ENROLLED IN THE STUDY. THEREFORE, FURTHER INFORMATION REGARDING THE PATIENT'S CONDITION IS NOT AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2010: ON (B)(6) 2010, THE PATIENT WAS REPORTED TO BE WELL (BLOOD PRESSURE 93/50, BILIRUBIN 168 AND CREATININE 143). THE PHYSICIAN REPORTED THE FOLLOWING ACTION ITEMS: CHOLESTATIC LIVER TEST, RENAL IMPAIRMENT DUE TO #3 AND/OR DEHYDRATION, HYPERCALCEMIA DD LYTIC FOCI, INCREASED VITAMIN D, INCREATED PTHRP (ANALYSIS UNDERWAY), ANEMIA WITHOUT KNOWN CAUSE DD DUE TO #2, DEFICIENCIES DUE TO CELLCEPT (ANALYSIS UNDERWAY). THE FOLLOWING TREATMENTS WERE ALSO IN PROGRESS: START INFUSION NACL 2 LITERS, CONSULTATION WITH DIETICIAN, LIVER ULTRASOUND (CHOLANGIOGRAPHY/DILATED BILE DUCTS), PTHRP AND 1.25-DI-OH VITAMIN D DETERMINATIONS ADDED IN THE CONTEXT OF THE HYPERCALCEMIA. ON (B)(6) 2010, THE PATIENT WAS AGAIN REPORTED TO BE WELL (BLOOD PRESSURE 107/60, BILIRUBIN 174 AND CREATININE 131). A LIVER ULTRASOUND REVEALED THAT THE BILE DUCTS WERE OPEN AND NOT DILATED; HOWEVER, THE STENT DID MIGRATE. THE FOLLOWING WERE REPORTED ACTION ITEMS: CHOLESTATIC LIVER TEST, RENAL IMPAIRMENT DUE TO #3 AND/OR DEHYDRATION, HYPERCALCEMIA DD LYTIC FOCI, INCREASED VITAMIN D, INCREATED PTHRP (ANALYSIS UNDERWAY), ANEMIA WITHOUT KNOWN CAUSE DD DUE TO #2, DEFICIENCIES DUE TO CELLCEPT (ANALYSIS UNDERWAY), WALLSTENT IN COMMON BILE DUCT SEEMS TO HAVE MIGRATED. THE FOLLOWING TREATMENTS WERE ALSO IN PROGRESS: STOP INFUSION OF NACL 2 LITERS, SUPPORT STOCKINGS, PLAN AN ADDITIONAL ERCP.

Description of Event or Problem · 1

THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04718 REFERS TO THE 8X80 STENT WHICH WAS NOT IMPLANTED, WHILE THIS REPORT REFERS TO THE 10X80 STENT WHICH WAS IMPLANTED FOR A PERIOD OF 7 DAYS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY RX COVERED STENTS WERE USED DURING A BILIARY STENTING PROCEDURE WITHIN THE PROXIMAL PORTION OF THE COMMON BILE DUCT ON (B)(6) 2010. THIS PROCEDURE WAS CONDUCTED AS PART OF THE (B)(4). ACCORDING TO THE COMPLAINANT, A CHOLANGIOGRAM PERFORMED ON (B)(6) 2010 REVEALED A PROXIMAL BILIARY STRICTURE, WHICH HAD BEEN PREVIOUSLY TREATED WITH A PLASTIC STENT. DURING THE (B)(6) STENT PLACEMENT PROCEDURE, THE PLASTIC STENT WAS NOT REMOVED, AND A SPHINCTEROTOMY WAS NOT PERFORMED. DUE TO THE RELATIVE SMALL CALIBER OF THE DONOR DUCT, AN 8X80 WALLFLEX STUDY STENT WAS CHOSEN AND PLACED ACROSS THE STRICTURE; THIS STENT, HOWEVER, IMMEDIATELY MIGRATED (MOST LIKELY DUE TO THE SMALLER DIAMETER). THIS STENT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN WAS THEN ABLE TO SUCCESSFULLY IMPLANT THE 10X80 WALLFLEX ACROSS THE STRICTURE. ON (B)(6) 2010, THE PATIENT EXPERIENCED NAUSEA AND VOMITING. ADDITIONALLY, AN ERCP WAS CONDUCTED DUE TO A RISE IN BILIRUBIN LEVELS. THE PHYSICIAN NOTICED THAT THE IMPLANTED STENT HAD MIGRATED AS WELL. THE PHYSICIAN SUSPECTS THAT THE MIGRATION WAS DUE TO THE LOCAL ANATOMY, WITH ONLY A RELATIVELY SHORT PART OF THE STENT ABOVE THE STENOSIS. THIS STENT WAS SUCCESSFULLY AND UNEVENTFULLY REMOVED USING FORCEPS, AND ANOTHER STENT WAS IMPLANTED. THE NAUSEA AND VOMITING WERE REPORTED TO HAVE BEEN "RESOLVED" ON (B)(6) 2010. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. BECAUSE THE STENT WAS REMOVED, THE PATIENT IS NO LONGER ENROLLED IN THE STUDY. THEREFORE, FURTHER INFORMATION REGARDING THE PATIENT'S CONDITION IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	M00570840	13051894

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Required Intervention