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

Report

Report Number: 3005099803-2010-02869
Event Type: Injury
Date Received: June 24, 2010
Date of Event: April 30, 2010
Report Date: June 3, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: K083627
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AS THE DEVICE HAS NOT BEEN RETURNED, BOSTON SCIENTIFIC COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED AS PER THE BOSTON SCIENTIFIC (B)(4) STUDY PROTOCOL.

Additional Manufacturer Narrative · 1

(B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND 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

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED DURING A BILIARY STENT PROCEDURE IN THE DISTAL BILIARY DUCT, PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE STENT WAS PLACED TO TREAT A BENIGN BILIARY STRICTURE SECONDARY TO CHRONIC PANCREATITIS. A SPHINCTEROTOMY WAS PERFORMED DURING THE PROCEDURE, AND THE STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. ON (B)(6) 2010, 4 DAYS POST STENT PLACEMENT, THE PATIENT WAS HOSPITALIZED DUE TO ABDOMINAL PAIN WITH AN ONSET DATE OF (B)(6) 2010. THE PATIENT WAS TREATED MEDICALLY, INCLUDING ANALGESIA. THE PATIENT WAS DISCHARGED ON (B)(6) 2010, AND THE EVENT WAS REPORTED AS RESOLVED WITH RESIDUAL EFFECTS. THE STENT REMAINS IMPLANTED. THE RELATIONSHIP BETWEEN THIS EVENT AND THE STENT WAS ASSESSED AS POSSIBLE BY THE STUDY INVESTIGATOR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE JULY 12, 2010: ON (B)(6) 2010, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PREDOMINATELY RIGHT-SIDED HYPOCHONDRIAL PAIN THAT WORSENED UNTIL "SHE FOUND IT HARD TO BEAR." THE PATIENT HAD VOMITING AND CONTINUOUS IRRADIATING ABDOMINAL PAIN AT THE WAIST. ADDITIONAL SYMPTOMS INCLUDED JAUNDICE OF THE SUBCONJUNCTIVAL MUCOSA, ABDOMEN PAINFUL ON PALPITATION AND ABSCENCE OF PERISTALSIS. AN ABDOMINAL X-RAY WAS NEGATIVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT. ON (B)(6) 2010, A CT SCAN REVEALED A NON-DISPLACED STENT THAT WAS CORRECTLY PLACED WITH NO MIGRATION OR PERFORATION. A LEFT-SIDED LUTEAL CYST WAS OBSERVED. ON (B)(6) 2010 AN ABDOMINAL X-RAY REVEALED THAT THE STENT WAS CORRECTLY PLACED AND EXPANDED. PATIENT WAS REPORTED AS MAKING GOOD PROGRESS DURING HOSPITALIZATION, WITH PROGRESSIVE IMPROVEMENT IN ABDOMINAL PAIN AFTER PRESCRIBING MILD OPIOID ANALGESICS AND PARACETAMOL. VITAL SIGNS WERE NORMAL WITH GOOD TOLERANCE TO ORAL INGESTION. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. THE PATIENT'S RESIDUAL PAIN WAS BEING TREATED WITH MEDICATION AFTER DISCHARGE, AND NO ADDITIONAL TREATMENT WAS REQUIRED. DISCHARGE DIAGNOSES WERE CHRONIC PANCREATITIS AND OVARIAN CYST. THE SYMPTOMS OF JAUNDICE, VOMITING, ABSCENCE OF PERISTALSIS WERE REPORTED AS RELATED TO THE PATIENT'S HISTORY OF CHRONIC PANCREATITIS AND THE OVARIAN CYST, AND WERE NOT STENT RELATED. THERE IS A DISCREPANCY IN THE DATE OF STENT PLACEMENT. IT WAS ORIGINALLY REPORTED AS (B)(6) 2010 AND ADDITIONAL INFORMATION PROVIDED THE DATE AS (B)(6) 2010. ATTEMPTS TO OBTAIN CLARIFICATION HAVE BEEN UNSUCCESSFUL TO DATE. A SUPPLEMENT REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC ON SEPTEMBER 16, 2010. THE CORRECT STENT IMPLANT DATE IS (B)(6) 2010 (NOT (B)(6) 2010 AS PREVIOUSLY REPORTED). THE STRICTURE HAD PREVIOUSLY BEEN TREATED WITH A SPHINCTEROTOMY AND A PLASTIC STENT. THE PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED PRIOR TO STUDY STENT PLACEMENT DURING THE STUDY STENT PLACEMENT PROCEDURE. A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE.

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 PROCEDURE IN THE DISTAL BILIARY DUCT, PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE STENT WAS PLACED TO TREAT A BENIGN BILIARY STRICTURE SECONDARY TO CHRONIC PANCREATITIS. A SPHINCTEROTOMY WAS PERFORMED DURING THE PROCEDURE, AND THE STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. ON (B)(6) 2010, 4 DAYS POST STENT PLACEMENT, THE PATIENT WAS HOSPITALIZED DUE TO ABDOMINAL PAIN WITH AN ONSET DATE OF (B)(6) 2010. THE PATIENT WAS TREATED MEDICALLY, INCLUDING ANALGESIA. THE PATIENT WAS DISCHARGED ON (B)(6) 2010, AND THE EVENT WAS REPORTED AS RESOLVED WITH RESIDUAL EFFECTS. THE STENT REMAINS IMPLANTED. THE RELATIONSHIP BETWEEN THIS EVENT AND THE STENT WAS ASSESSED AS POSSIBLE BY THE STUDY INVESTIGATOR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE JULY 12, 2010: ON (B)(6) 2010, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PREDOMINATELY RIGHT-SIDED HYPOCHONDRIAL PAIN THAT WORSENED UNTIL "SHE FOUND IT HARD TO BEAR." THE PATIENT HAD VOMITING AND CONTINUOUS IRRADIATING ABDOMINAL PAIN AT THE WAIST. ADDITIONAL SYMPTOMS INCLUDED JAUNDICE OF THE SUBCONJUNCTIVAL MUCOSA, ABDOMEN PAINFUL ON PALPITATION AND ABSCENCE OF PERISTALSIS. AN ABDOMINAL X-RAY WAS NEGATIVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT. ON (B)(6) 2010, A CT SCAN REVEALED A NON-DISPLACED STENT THAT WAS CORRECTLY PLACED WITH NO MIGRATION OR PERFORATION. A LEFT-SIDED LUTEAL CYST WAS OBSERVED. ON (B)(6) 2010 AN ABDOMINAL X-RAY REVEALED THAT THE STENT WAS CORRECTLY PLACED AND EXPANDED. PATIENT WAS REPORTED AS MAKING GOOD PROGRESS DURING HOSPITALIZATION, WITH PROGRESSIVE IMPROVEMENT IN ABDOMINAL PAIN AFTER PRESCRIBING MILD OPIOID ANALGESICS AND PARACETAMOL. VITAL SIGNS WERE NORMAL WITH GOOD TOLERANCE TO ORAL INGESTION. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. THE PATIENT'S RESIDUAL PAIN WAS BEING TREATED WITH MEDICATION AFTER DISCHARGE, AND NO ADDITIONAL TREATMENT WAS REQUIRED. DISCHARGE DIAGNOSES WERE CHRONIC PANCREATITIS AND OVARIAN CYST. THE SYMPTOMS OF JAUNDICE, VOMITING, ABSCENCE OF PERISTALSIS WERE REPORTED AS RELATED TO THE PATIENT'S HISTORY OF CHRONIC PANCREATITIS AND THE OVARIAN CYST, AND WERE NOT STENT RELATED. THERE IS A DISCREPANCY IN THE DATE OF STENT PLACEMENT. IT WAS ORIGINALLY REPORTED AS (B)(6) 2010 AND ADDITIONAL INFORMATION PROVIDED THE DATE AS (B)(6) 2010. ATTEMPTS TO OBTAIN CLARIFICATION HAVE BEEN UNSUCCESSFUL TO DATE. A SUPPLEMENT REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

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 PROCEDURE IN THE DISTAL BILIARY DUCT, PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE STENT WAS PLACED TO TREAT A BENIGN BILIARY STRICTURE SECONDARY TO CHRONIC PANCREATITIS. A SPHINCTEROTOMY WAS PERFORMED DURING THE PROCEDURE, AND THE STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. ON (B)(6), 2010, 4 DAYS POST STENT PLACEMENT, THE PATIENT WAS HOSPITALIZED DUE TO ABDOMINAL PAIN WITH AN ONSET DATE OF (B)(6), 2010. THE PATIENT WAS TREATED MEDICALLY, INCLUDING ANALGESIA. THE PATIENT WAS DISCHARGED ON (B)(6), 2010, AND THE EVENT WAS REPORTED AS RESOLVED WITH RESIDUAL EFFECTS. THE STENT REMAINS IMPLANTED. THE RELATIONSHIP BETWEEN THIS EVENT AND THE STENT WAS ASSESSED AS POSSIBLE BY THE STUDY INVESTIGATOR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL 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
1	WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	M00570830	0013142318

Patients

Seq	Age	Sex	Outcome	Treatment
1	36 YR		Hospitalization\| R