BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2152455 · Received June 21, 2011

    Report

    Report Number
    9612164-2011-00623
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (FAILURE TO DELIVER THE STENT, STENT EMBOLISM). RESULTS AND CONCLUSIONS: (PT WITH 3 VESSEL DISEASE, 80-100% STENOSED LESION).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 3.0 MM DIAMETER X 15MM LENGTH INTEGRITY RAPID EXCHANGE (RX) BARE METAL STENT TO TREAT A LESION WITH 80-100% STENOSIS. PT IS REPORTED TO HAVE HAD THREE VESSEL DISEASE. THE TARGET LESION WAS PRE-DILATED USING A 3.5 X 15 MM SPRINTER BALLOON. TWO ATTEMPTS WERE MADE TO DELIVER THE INTEGRITY DEVICE TO THE TARGET LESION. DIFFICULTIES WERE ENCOUNTERED PASSING THE STENT THROUGH THE LESION AND THE DELIVERY SYSTEM WAS WITHDRAWN BACK INTO THE GUIDE CATHETER. DURING WITHDRAWAL THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND COULD NOT BE LOCATED. THERE WAS NO DAMAGE OR MOVEMENT EVIDENT ON THE STENT DURING PREPARATION OF THE DEVICE PRIOR TO INSERTION INTO THE PT. ONE OTHER BRAND STENT WAS SUBSEQUENTLY IMPLANTED. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT DELIVERY SYSTEM MAF MEDTRONIC IRELAND NA 0004076984

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK