BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3200840 · Received July 2, 2013

    Report

    Report Number
    9612164-2013-00681
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (FAILURE TO DELIVER AND STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿SEVERE CALCIFICATION. (DEFORMATION PROBLEM) EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿SEVERE CALCIFICATION. INHERENT RISK OF PROCEDURE ¿ (FAILURE TO DELIVER AND STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DEPLOY ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO A SEVERELY CALCIFIED LESION AT THE RCA BUT THE DEVICE COULD NOT CROSS. LESION HAD BEEN PRE-DILATED. NO PATIENT COMPLICATION REPORTED. ON PRODUCT RETURN THE STENT APPEARED DAMAGED. EVALUATION SUMMARY: THE STENT WAS RETURNED ON THE BALLOON. THE 1ST DISTAL SEGMENT WAS PARTIALLY COVERING THE DISTAL MARKER BAND. THE DISTAL STENT SEGMENTS WERE RAISED, DEFORMED AND SLIGHTLY STRETCHED. THE DISTAL TIP WAS DAMAGED. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303205 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005702248

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR