BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2123451 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-02001
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS SEVERELY DAMAGED WITH THE STENT WIRES UNRAVELED AND THE STENT COMPRESSED AT ONE END. THE STENT COVER WAS PRESENT AND VISIBLE ON THE STENT. ONLY THE STENT WAS RETURNED FOR ANALYSIS; THE DELIVERY SYSTEM WAS NOT RETURNED. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT. FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE DEVICE IS CONTRAINDICATED FOR PLACEMENT IN BENIGN STRICTURES CAUSED BY BENIGN TUMORS AND THE DEVICE SHOULD NOT BE MOVED OR REMOVED AFTER THE COMPLETION OF THE INITIAL STENT PLACEMENT PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS "USER/USE ERROR." A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF THE RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX FULLY COVERED RX BILIARY STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A BENIGN BILIARY STENOSIS. THE DECISION TO IMPLANT THE METAL STENT WAS MADE TO AVOID A SURGICAL PROCEDURE. THE STENT WAS IMPLANTED SUCCESSFULLY WITHOUT COMPLICATIONS. THE PHYSICIAN PLANNED TO PERFORM A SECOND ERCP PROCEDURE (B)(6) FOLLOWING THE INITIAL STENT PLACEMENT TO REMOVE THE STENT. HOWEVER, THE PATIENT DID NOT RETURN TO THE HOSPITAL UNTIL APPROXIMATELY (B)(6) FOLLOWING THE STENT PLACEMENT. ON (B)(6) 2011, THE PATIENT PRESENTED WITH ELEVATED LEVELS OF BILIARY BLOOD INDICATORS AND IT WAS DETERMINED THAT THE STENT WAS BLOCKED/OCCLUDED. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT ENDOSCOPICALLY BUT WAS UNSUCCESSFUL. THE STENT WAS REMOVED SURGICALLY. FOLLOWING THE STENT REMOVAL, IT WAS NOTED THAT THE COVER OF THE STENT WAS NO LONGER PRESENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE STENT REMOVAL WAS REPORTED TO BE "STABLE." NOTE: THE INFORMATION AVAILABLE INDICATES THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU). THE DFU STATES THAT THE DEVICE IS "INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS" AND THE STENT "SHOULD NOT BE MOVED OR REMOVED AFTER COMPLETION OF THE INITIAL STENT PLACEMENT PROCEDURE." HOWEVER, ACCORDING TO THE COMPLAINANT, THE STENT WAS USED FOR THE TREATMENT OF A BENIGN BILIARY STENOSIS WITH A PLANNED REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX FULLY COVERED RX BILIARY STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A BENIGN BILIARY STENOSIS. THE DECISION TO IMPLANT THE METAL STENT WAS MADE TO AVOID A SURGICAL PROCEDURE. THE STENT WAS IMPLANTED SUCCESSFULLY WITHOUT COMPLICATIONS. THE PHYSICIAN PLANNED TO PERFORM A SECOND ERCP PROCEDURE 6 MONTHS FOLLOWING THE INITIAL STENT PLACEMENT TO REMOVE THE STENT. HOWEVER, THE PATIENT DID NOT RETURN TO THE HOSPITAL UNTIL APPROXIMATELY 22 MONTHS FOLLOWING THE STENT PLACEMENT. ON (B)(6), 2011, THE PATIENT PRESENTED WITH ELEVATED LEVELS OF BILIARY BLOOD INDICATORS AND IT WAS DETERMINED THAT THE STENT WAS BLOCKED/OCCLUDED. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT ENDOSCOPICALLY BUT WAS UNSUCCESSFUL. THE STENT WAS REMOVED SURGICALLY. FOLLOWING THE STENT REMOVAL, IT WAS NOTED THAT THE COVER OF THE STENT WAS NO LONGER PRESENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE STENT REMOVAL WAS REPORTED TO BE "STABLE." NOTE: THE INFORMATION AVAILABLE INDICATES THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU). THE DFU STATES THAT THE DEVICE IS "INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS" AND THE STENT "SHOULD NOT BE MOVED OR REMOVED AFTER COMPLETION OF THE INITIAL STENT PLACEMENT PROCEDURE." HOWEVER, ACCORDING TO THE COMPLAINANT, THE STENT WAS USED FOR THE TREATMENT OF A BENIGN BILIARY STENOSIS WITH A PLANNED 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 M00570520 0012349106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention