BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT® ENDOPROSTHESIS

    MDR report key: 4240520 · Received November 10, 2014

    Report

    Report Number
    2134265-2014-06961
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DI: (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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.   (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2014-06960. IT WAS REPORTED THAT DEPLOYMENT ISSUE AND STENT MIGRATION OCCURRED. THE TARGET LESION WAS A COARCTATION IN THE APEX OF THE CURVE OF THE AORTIC ARCH. A 20X40/10FR 75CM WALLSTENT® ENDOPROSTHESIS STENT WAS ADVANCED AND DEPLOYED IN THE LESION. WHILE MEASURING PRESSURES, THE STENT MIGRATED TO APPROXIMATELY 70-80CM. AN UNSPECIFIED SHEATH WAS USED TO PUSH THE STENT BACK UP TO APPROXIMATELY 40CM AND ENDED IN THE PROXIMAL DESCENDING AORTA, WHICH WAS DETERMINED TO BE THE MOST DESIRABLE ALTERNATIVE LOCATION. THE STENT WAS THEN POST DILATED USING AN UNSPECIFIED LARGE BALLOON CATHETER. A 24X45/11FR 75CM WALLSTENT® ENDOPROSTHESIS STENT WAS ADVANCED AND DEPLOYED IN THE TARGET LESION; HOWEVER, IT ALSO MIGRATED TO APPROXIMATELY 40CM AND ENDED UP IN THE PROXIMAL DESCENDING AORTA, OVERLAPPING THE FIRST STENT. BOTH STENTS WERE POST DILATED WITH AN UNSPECIFIED BALLOON CATHETER. AS THE PHYSICIAN WAS COMPLETING THE PROCEDURE, STENT MOVEMENT WAS BEING MONITORED. AFTER AN HOUR OF MONITORING, THE PHYSICIAN ASSURED THAT THERE WAS NO STENT MOVEMENT. BOTH STENTS WERE SECURE AT THE END OF THE PROCEDURE. THE PHYSICIAN NOTED THAT THE TWO STENTS DID NOT FULLY OPEN OR WERE NOT STRONG ENOUGH FOR THE MORPHOLOGY, WHICH CONTRIBUTED TO STENT MIGRATION. THE PROCEDURE WAS COMPLETED USING A NON BSC BALLOON EXPANDABLE STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723011 WALLSTENT® ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965404300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention