BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR SD

    MDR report key: 1003414 · Received February 21, 2008

    Report

    Report Number
    2134265-2008-00517
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RENAL ARTERY STENTING PROCEDURE, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN THE CALCIFIED LEFT RENAL ARTERY. ACCESS TO THE LEFT KIDNEY WAS OBTAINED VIA A V18 GUIDE WIRE AND THE LESION WAS PREDILATED WITH A 20X6MM BALLOON CATHETER. THE 7X19X90 CM EXPRESS VASCULAR SD STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AGAINST RESISTANCE TO THE LESION AND DEPLOYED SUCCESSFULLY. FOLLOWING STENT DEPLOYMENT, DIFFICULTY WAS EXPERIENCED DEFLATING THE BALLOON. IT WAS NOTED THAT THE BALLOON "CAUGHT" ON THE STENT; HOWEVER, THE STENT REMAINED IMPLANTED. THE PHYSICIAN BEGAN "TWISTING" THE BALLOON IN ORDER TO WITHDRAW IT. DUE TO THE FACT THAT THE BALLOON FAILED TO COMPLETELY REWRAP, THE SDS COULD NOT BE WITHDRAWN THROUGH THE SHEATH. THEREFORE, THE SHEATH AND SDS WERE WITHDRAWN AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "OK". THIS DEVICE IS OUS ONLY, BUT THERE IS A SAME OR SIMILAR DEVICE MARKED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR SD PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM NIN BOSTON SCIENTIFIC NA 7379422

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR