BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1706305 · Received June 2, 2010

    Report

    Report Number
    3005099803-2010-02440
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 ENTERAL COLONIC STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE ASCENDING COLON, PERFORMED ON (B) (6) 2010. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN ATTEMPTED TO PLACE THE STENT USING A JAGWIRE 4.5MM, BUT THE GUIDEWIRE APPEARED TOO SHORT FOR THE PROCEDURE. NO MALFUNCTION WAS REPORTED WITH THE GUIDEWIRE. THE PHYSICIAN DID NOT THINK HE HAD ANOTHER GUIDEWIRE THAT WAS LONG ENOUGH, SO HE DECIDED TO CONTINUE WITH THE SAME GUIDEWIRE. WHILE PUSHING THE STENT TOWARDS ITS DESIRED LOCATION, OFF OF THE GUIDEWIRE, THE PHYSICIAN ACCIDENTALLY PERFORATED THE PATIENT'S COLON. THE PERFORATION WAS NOTICED AT THE END OF THE PROCEDURE, AFTER THE STENT PLACEMENT AS EVIDENCED BY SWELLING. THE PATIENT WENT INTO SHOCK A COUPLE OF HOURS LATER, AND WAS IN TOO POOR OF A CONDITION WITH ADVANCED CANCER TO WITHSTAND SURGERY. THE PATIENT DIED THE SAME DAY, ON (B) (6) 2010, WITH A CAUSE OF DEATH REPORTED AS PERFORATION. NO AUTOPSY WAS PERFORMED. THE PHYSICIAN REPORTED NO MALFUNCTION OF THE STENT, AND ASSESSED THE RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE WALLFLEX STENT AS "NONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565060 0013318879

    Patients

    Seq Age Sex Outcome Treatment
    1 Death JAGWIRE 4,5 M