BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3212271 · Received July 9, 2013

    Report

    Report Number
    9612164-2013-00697
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 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 AND CONCLUSIONS: (FAILURE TO DELIVER AND STENT DEFORMATION). (LESION MORPHOLOGY). 90-95% STENOSIS AND SEVERE CALCIFICATION. (DEFORMATION PROBLEM). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER 1 ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO A SEVERELY CALCIFIED LESION AT LCX WITH 90%-95% STENOSIS BUT THE DEVICE COULD NOT CROSS. PHYSICIAN GAVE UP THE OPERATION. PATIENT OVERALL OK EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED AND DAMAGED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. A NUMBER OF STRUTS ON THE 1ST AND 2ND DISTAL STENT SEGMENTS WERE RAISED AND PULLED PROXIMALLY OVER THE STENT. 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
    312577 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006670776

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR