BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1902586 · Received November 18, 2010

    Report

    Report Number
    3005099803-2010-04789
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    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

    A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. 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 TO ASSESS THE SAFETY AND PERFORMANCE OF TEMPORARY PLACEMENT OF THE WALLFLEX BILIARY RX FULLY COVERED STENTS AS A TREATMENT OF BILIARY OBSTRUCTION RESULTING FROM BENIGN BILE DUCT STRICTURES. STENT MIGRATION AND PAIN ARE BOTH LISTED IN THE DFU FOR THIS PRODUCT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT ONLY A DEPLOYED STENT WAS RETURNED FOR ANALYSIS. THE STENT MEASURED 80MM IN LENGTH AND 10MM IN DIAMETER WHICH IS WITHIN SPECIFICATION. THE STENT WAS FULLY EXPANDED AND THERE WERE NO ISSUE NOTED WITH THE PROFILE. DEVICE ANALYSIS DETERMINED THAT THERE WERE NO ISSUES WITH THE RETURNED DEVICE WHICH COULD CONTRIBUTE TO THE COMPLAINT INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. 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 (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 BILIARY OBSTRUCTION RESULTING FROM BENIGN BILE DUCT STRICTURES. STENT MIGRATION AND PAIN ARE BOTH LISTED IN THE DFU FOR THIS PRODUCT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    (B)(4) - MEDICAL INTERVENTION REQUIRED; HOSPITALIZED; PUS; STONES. (B)(4) - THE REPORTED ISSUE OF STENT MIGRATED. 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. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS IMPLANTED WITHIN THE PROXIMAL COMMON BILE DUCT OF A PATIENT ON (B)(6) 2010 AS PART OF THE (B)(4). ACCORDING TO THE COMPLAINANT, THE PATIENT HAD PREVIOUSLY UNDERGONE A LIVER TRANSPLANT ON (B)(6) 2007. ON (B)(6) 2010, LIVER FUNCTION TESTS WERE RECORDED, AND BILIARY OBSTRUCTIVE SYMPTOMS WERE ASSESSED WHICH INCLUDED ITCHING. A PRE-STUDY STENT PLACEMENT CHOLANGIOGRAM REVEALED A PROXIMAL BILIARY STRICTURE. THE STRICTURE HAD PREVIOUSLY BEEN TREATED WITH A SPHINCTEROTOMY AND A PLASTIC STENT AND BALLOON. A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE. THE PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED PRIOR TO STUDY STENT PLACEMENT DURING THE STUDY STENT PLACEMENT PROCEDURE. THE 10 MM X 80 MM STENT WAS DEPLOYED IN SATISFACTORY POSITION ACROSS THE STRICTURE. DURING STUDY STENT PLACEMENT, THE PATIENT EXPERIENCED EPIGASTRIC PAIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, 168 DAYS POST STUDY STENT PLACEMENT, THE PATIENT PRESENTED FOR PER PROTOCOL STUDY STENT REMOVAL. LIVER FUNCTION TESTS WERE RECORDED, AND BILIARY OBSTRUCTIVE SYMPTOMS WERE ASSESSED WHICH INCLUDED JAUNDICE AND ITCHING. A CHOLANGIOGRAM REVEALED THE STUDY STENT HAD MIGRATED TWO CENTIMETERS FROM THE AMPULLA INTO THE COMMON BILE DUCT. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE "POSSIBLE", PER THE INVESTIGATOR. ALSO ON (B)(6) 2010 THE PATIENT HAD STONES AND DEBRIS REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE STRICTURE REMAINED ABOVE THE MIGRATED STUDY STENT. AN ATTEMPT WAS MADE TO REMOVE THE STUDY STENT, BUT WAS UNSUCCESSFUL DUE TO THE MIGRATION. A PLASTIC STENT WAS PLACED WITHIN THE STUDY STENT WITH GOOD DRAINAGE. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. AFTER THE ATTEMPTED STUDY STENT REMOVAL, THE PATIENT WAS HOSPITALIZED WITH MID-ABDOMINAL PAIN. THE PATIENT WAS TREATED MEDICALLY. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE "UNRELATED", PER THE INVESTIGATOR. IN THE NEXT FEW WEEKS A SECOND ATTEMPT TO REMOVE THE STUDY STENT WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS IMPLANTED WITHIN THE PROXIMAL COMMON BILE DUCT OF A PATIENT, ON (B)(6) 2010, AS PART OF THE (B)(4) STUDY CLINICAL TRIAL. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD PREVIOUSLY UNDERGONE A LIVER TRANSPLANT ON (B)(6) 2007. ON (B)(6) 2010, LIVER FUNCTION TESTS WERE RECORDED, AND BILIARY OBSTRUCTIVE SYMPTOMS WERE ASSESSED WHICH INCLUDED ITCHING. A PRE-STUDY STENT PLACEMENT CHOLANGIOGRAM REVEALED A PROXIMAL BILIARY STRICTURE. THE STRICTURE HAD PREVIOUSLY BEEN TREATED WITH A SPHINCTEROTOMY AND A PLASTIC STENT AND BALLOON. A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE. THE PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED PRIOR TO STUDY STENT PLACEMENT DURING THE STUDY STENT PLACEMENT PROCEDURE. THE 10 MM X 80 MM STENT WAS DEPLOYED IN SATISFACTORY POSITION ACROSS THE STRICTURE. DURING STUDY STENT PLACEMENT, THE PATIENT EXPERIENCED EPIGASTRIC PAIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, 168 DAYS POST STUDY STENT PLACEMENT, THE PATIENT PRESENTED FOR PER PROTOCOL STUDY STENT REMOVAL. LIVER FUNCTION TESTS WERE RECORDED, AND BILIARY OBSTRUCTIVE SYMPTOMS WERE ASSESSED WHICH INCLUDED JAUNDICE AND ITCHING. A CHOLANGIOGRAM REVEALED THE STUDY STENT HAD MIGRATED TWO CENTIMETERS FROM THE AMPULLA INTO THE COMMON BILE DUCT. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE "POSSIBLE," PER THE INVESTIGATOR. ALSO ON (B)(6) 2010 THE PATIENT HAD STONES AND DEBRIS REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE STRICTURE REMAINED ABOVE THE MIGRATED STUDY STENT. AN ATTEMPT WAS MADE TO REMOVE THE STUDY STENT, BUT WAS UNSUCCESSFUL DUE TO THE MIGRATION. A PLASTIC STENT WAS PLACED WITHIN THE STUDY STENT WITH GOOD DRAINAGE. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. AFTER THE ATTEMPTED STUDY STENT REMOVAL, THE PATIENT WAS HOSPITALIZED WITH MID-ABDOMINAL PAIN. THE PATIENT WAS TREATED MEDICALLY. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE "UNRELATED," PER THE INVESTIGATOR. IN THE NEXT FEW WEEKS A SECOND ATTEMPT TO REMOVE THE STUDY STENT WILL BE PERFORMED. ON (B)(4) 2010 THE FOLLOWING INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC: THE RELATIONSHIP BETWEEN THE STENT MIGRATION AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE "UNRELATED," PER THE INVESTIGATOR. AS THE ORIGINAL STRICTURE HAD NOT RESOLVED, A PLASTIC STENT WAS PLACED WITHIN THE STUDY STENT, WITH GOOD DRAINAGE. PER THE (B)(4) 2010 CORRESPONDENCE WITH THE INVESTIGATOR, FORESHORTENING AT THE PROXIMAL END OF THE STENT, WHICH WAS ORIGINALLY ABOVE THE STRICTURE, LED TO FULL/PARTIAL EXPOSURE OF THE STRICTURE. ON (B)(6) 2010, 198 DAYS POST STUDY STENT PLACEMENT, THE STUDY STENT WAS REMOVED AND ANOTHER STENT WAS PLACED DUE TO A RECURRENT STRICTURE. BILIARY OBSTRUCTION SYMPTOM WERE ASSESSED WHICH INCLUDED ITCHING. THE STUDY STENT WAS REMOVED BY USING FORCEPS TO GRASP THE DISTAL END OF THE STENT AND REMOVING IT FROM THE SUBJECT WITH THE SCOPE. THERE WERE NO CLINICALLY SIGNIFICANT OR TECHNICAL COMPLICATIONS DURING THE STUDY STENT REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS IMPLANTED WITHIN THE PROXIMAL COMMON BILE DUCT OF A PATIENT, ON (B)(6) 2010, AS PART OF THE (B)(6) STUDY CLINICAL TRIAL. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD PREVIOUSLY UNDERGONE A LIVER TRANSPLANT ON (B)(6) 2007. ON (B)(6) 2010, LIVER FUNCTION TESTS WERE RECORDED, AND BILIARY OBSTRUCTIVE SYMPTOMS WERE ASSESSED WHICH INCLUDED ITCHING. A PRE-STUDY STENT PLACEMENT CHOLANGIOGRAM REVEALED A PROXIMAL BILIARY STRICTURE. THE STRICTURE HAD PREVIOUSLY BEEN TREATED WITH A SPHINCTEROTOMY AND A PLASTIC STENT AND BALLOON. A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE. THE PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED PRIOR TO STUDY STENT PLACEMENT DURING THE STUDY STENT PLACEMENT PROCEDURE. THE 10 MM X 80 MM STENT WAS DEPLOYED IN SATISFACTORY POSITION ACROSS THE STRICTURE. DURING STUDY STENT PLACEMENT, THE PATIENT EXPERIENCED EPIGASTRIC PAIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, 168 DAYS POST STUDY STENT PLACEMENT, THE PATIENT PRESENTED FOR PER PROTOCOL STUDY STENT REMOVAL. LIVER FUNCTION TESTS WERE RECORDED, AND BILIARY OBSTRUCTIVE SYMPTOMS WERE ASSESSED WHICH INCLUDED JAUNDICE AND ITCHING. A CHOLANGIOGRAM REVEALED THE STUDY STENT HAD MIGRATED TWO CENTIMETERS FROM THE AMPULLA INTO THE COMMON BILE DUCT. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE 'POSSIBLE,' PER THE INVESTIGATOR. ALSO ON (B)(6) 2010 THE PATIENT HAD STONES AND DEBRIS REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE STRICTURE REMAINED ABOVE THE MIGRATED STUDY STENT. AN ATTEMPT WAS MADE TO REMOVE THE STUDY STENT, BUT WAS UNSUCCESSFUL DUE TO THE MIGRATION. A PLASTIC STENT WAS PLACED WITHIN THE STUDY STENT WITH GOOD DRAINAGE. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. AFTER THE ATTEMPTED STUDY STENT REMOVAL, THE PATIENT WAS HOSPITALIZED WITH MID-ABDOMINAL PAIN. THE PATIENT WAS TREATED MEDICALLY. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE 'UNRELATED,' PER THE INVESTIGATOR. IN THE NEXT FEW WEEKS A SECOND ATTEMPT TO REMOVE THE STUDY STENT WILL BE PERFORMED. ***ON (B)(6) 2010 THE FOLLOWING INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC: *** THE RELATIONSHIP BETWEEN THE STENT MIGRATION AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE 'UNRELATED,' PER THE INVESTIGATOR. AS THE ORIGINAL STRICTURE HAD NOT (B)(6) 2010 CORRESPONDENCE WITH THE INVESTIGATOR, FORESHORTENING AT THE PROXIMAL END OF THE STENT, WHICH WAS ORIGINALLY ABOVE THE STRICTURE, LED TO FULL/PARTIAL EXPOSURE OF THE STRICTURE. ON (B)(6) 2010, 198 DAYS POST STUDY STENT PLACEMENT, THE STUDY STENT WAS REMOVED AND ANOTHER STENT WAS PLACED DUE TO A RECURRENT STRICTURE. BILIARY OBSTRUCTION SYMPTOM WERE ASSESSED WHICH INCLUDED ITCHING. THE STUDY STENT WAS REMOVED BY USING FORCEPS TO GRASP THE DISTAL END OF THE STENT AND REMOVING IT FROM THE SUBJECT WITH THE SCOPE. THERE WERE NO CLINICALLY SIGNIFICANT OR TECHNICAL COMPLICATIONS DURING THE STUDY STENT REMOVAL.

    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 63 YR Hospitalization| R