BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3405767 · Received October 11, 2013

    Report

    Report Number
    9612164-2013-00980
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    September 12, 2013
    Report Date
    September 12, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE ¿ (DEFORMATION); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿ 70% STENOSIS AND LITTLE CALCIFICATION. CAUSED BY ANOTHER DEVICE ¿ (DEFORMATION NOT EVIDENT PRIOR TO USE OF KBT AND NO DAMAGE TO DEVICE PRIOR TO USE); (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW; NO DEVICE RETURN. CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ 70% STENOSIS AND LITTLE CALCIFICATION. 22 INHERENT RISK OF PROCEDURE ¿ (DEFORMATION); CAUSED BY ANOTHER DEVICE - (DEFORMATION NOT EVIDENT PRIOR TO USE OF KBT AND NO DAMAGE TO DEVICE PRIOR TO USE); NO DEVICE RETURN. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN SUCCESSFULLY DEPLOYED 1 RESOLUTE INTEGRITY DRUG-ELUTING STENT TO A LESION IN THE LAD ¿ LM WITH 70% STENOSIS AND LITTLE CALCIFICATION. LESION HAD NOT BEEN PRE-DILATED. POST-DILATATION WAS CARRIED OUT WITH NC SPRINTER. STENT APPOSITION WAS STUDIED BY IVUS. KISSING BALLOON TECHNIQUE WAS THEN PERFORMED IN ORDER TO ¿RE-OPEN¿ OSTIAL LCX. AFTER THAT, STENT DEFORMATION OF PROXIMAL STENT WAS FOUND. ANOTHER RESOLUTE INTEGRITY STENT WAS DEPLOYED AT LM TO COVER THE DEFORMED PROXIMAL STENT AFTER DILATATIONS WITH SEVERAL BALLOONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523030 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006100410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention