BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY OTW CORONARY STENT SYSTEM

    MDR report key: 2160195 · Received June 2, 2011

    Report

    Report Number
    9612164-2011-00518
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSIONS: DELIVERY THROUGH A PREVIOUSLY DEPLOYED STENT. NINETY NINE PERCENT STENOSIS. STENT DEFORMATION AND FAILURE TO DELIVER STENT. EVAL SUMMARY: THE DEVICE WAS RECEIVED FOR EVAL. THE TIP WAS DAMAGED. THE PROXIMAL SHAFT WAS FLATTENED DISTAL TO THE STRAIN RELIEF. THE DISTAL SHAFT WAS FLATTENED PROXIMAL TO THE BALLOON BOND. A NUMBER OF STRUTS ON THE PROXIMAL AND DISTAL SEGMENTS WERE FLARED AND DEFORMED. THE STENT WAS POSITIONED ON BALLOON BETWEEN THE MARKER BANDS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 3.0MM DIAMETER X 30MM LENGTH INTEGRITY OVER THE WIRE (OTW) CORONARY STENT TO THE OSTIAL PROXIMAL CIRCUMFLEX. THE INTEGRITY OTW GOT CAUGHT ON A PREVIOUSLY DEPLOYED STENT AS IT CROSSED THE LESION. ON REMOVAL FROM THE PT IT WAS NOTICED THAT THE STENT WAS DAMAGED. THE VESSEL WAS 99% STENOSED. PRE-DILATATION WAS PERFORMED. THE PT RECOVERED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY OTW CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0004802477

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK