BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3945184 · Received July 18, 2014

    Report

    Report Number
    9612164-2014-00971
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    May 19, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿DIFFUSE LESION AND 80% STENOSIS. (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ DIFFUSE LESION AND 80% STENOSIS. INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER 1 ENDEAVOR RESOLUTE DRUG-ELUTING STENT (2.50MM X 24MM) TO A DIFFUSE LESION IN THE LAD WITH 80% STENOSIS BUT THE DEVICE COULD NOT PASS THE LESION. THE LESION HAD BEEN PRE-DILATED. THE PHYSICIAN CHANGED ANOTHER DEVICE TO COMPLETE THE SURGERY. THE PATIENT IS GOOD. EVALUATION SUMMARY: THE HYPOTUBE WAS KINKED 31.3CM DISTAL TO THE STRAIN RELIEF. A NUMBER OF STENT STRUTS ON THE 8TH PROXIMAL SEGMENT WERE RAISED AND PULLED DISTALLY. THE REMAINING SEGMENTS WERE INTACT. 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
    422189 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006778051

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR