BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3972734 · Received August 1, 2014

    Report

    Report Number
    9612164-2014-01016
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 21, 2014
    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 ¿ (STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿ 99% STENOSIS, CALCIFICATION AND VESSEL TORTUOSITY. (DEFORMATION PROBLEM) EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ 99% STENOSIS, CALCIFICATION AND VESSEL TORTUOSITY. INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT (2.50MM X 8MM) TO A CALCIFIED LESION IN THE LCX WITH 99% STENOSIS <(>&<)> VESSEL TORTUOSITY BUT THE DEVICE COULD NOT CROSS THE LESION. THE PHYSICIAN GAVE UP THE SURGERY. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE HYPOTUBE WAS KINKED AT 73CM DISTAL TO THE STRAIN RELIEF. THE HYPOTUBE WAS ALSO KINKED AT THE STRAIN RELIEF. THERE WAS EVIDENCE OF STENT DEFORMATION ON THE DEVICE, THE 3RD DISTAL SEGMENT WAS RAISED AND STRETCHED STRUTS EVIDENT. THE DISTAL TIP OF THE CATHETER WAS SLIGHTLY STUBBED. 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
    450569 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006220503

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR