BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 3102839 · Received May 9, 2013

    Report

    Report Number
    3005099803-2013-03350
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE WAS NOT PROVIDED, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS. REFER TO MANUFACTURER REPORT # 3005099803-2013-03350 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT AND A WALLFLEX ENTERAL DUODENAL STENT WERE USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT PROCEDURE WAS AS A BRIDGE TO SURGERY FOR A BENIGN TUMOR WITHIN THE DESCENDING COLON. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. DURING THE PROCEDURE, WHEN TRYING TO DEPLOY THE WALLFLEX ENTERAL COLONIC STENT (THE SUBJECT OF THIS REPORT), RESISTANCE WAS FELT WHEN TRYING TO DEPLOY THE LAST 2CMS OF THE STENT AND THE WHITE HANDLE DETACHED. THEY TRIED TO DEPLOY THE STENT WITH DIFFERENT METHODS AND THE STENT EVENTUALLY DEPLOYED, BUT DUE TO MANIPULATION IT WAS PLACED TOO FAR PROXIMAL FROM THE LESION. A WALLFLEX ENTERAL DUODENAL STENT DEVICE (THE SUBJECT OF MFR. REPORT # 3005099803-2013-03350) WAS THEN PLACED WITHIN THE WALLFLEX ENTERAL COLONIC STENT WITHOUT ANY ISSUE. IT WAS REPORTED THAT DURING THE WEEKEND FOLLOWING THE PLACEMENT OF THE STENTS, THE WALLFLEX ENTERAL DUODENAL STENT STARTED PUSHING ON THE WALLFLEX ENTERAL COLONIC STENT AND CAUSED A MICRO-PERFORATION. IN THE PHYSICIAN'S ASSESSMENT, IT WAS UNABLE TO BE DETERMINED WHICH STENT CAUSED THE PERFORATION. AS THE STENTS WERE INITIALLY PLACED AS A BRIDGE TO SURGERY, THE PLANNED SURGERY FOR THE PATIENT WAS EXPEDITED AND BOTH STENTS WERE REMOVED. THE PATIENT WAS REPORTED TO BE STABLE POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204574 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565030 15648481

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention