BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3962451 · Received July 29, 2014

    Report

    Report Number
    9612164-2014-01003
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 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). PATIENTS CONDITION AFFECTED THE EFFECTIVENESS OF THE DEVICE (LESION MORPHOLOGY - STENOSED, CALCIFIED LESION). NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (DEVICE OR PROCEDURAL IMAGES HAVE NOT BEEN RETURNED FOR REVIEW). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE (STENT DEFORMATION). DEVICE FAILURE RELATED TO PATIENT CONDITION (LESION MORPHOLOGY - STENOSED, CALCIFIED LESION). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES HAVE NOT BEEN RETURNED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT A STENOSED, CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. THE VESSEL WAS PRE-DILATED WITH A SPRINTER LEGEND BALLOON. DURING THE SURGERY, THE PHYSICIAN DECIDED TO USE A 2.25MM DIAMETER X 24 MM LENGTH ENDEAVOR RESOLUTE (RX) DRUG ELUTING STENT BUT THE DEVICE FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE DEVICE WAS DEFORMED ONCE IT WAS REMOVED FROM THE PATIENT. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE SURGERY. 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
    442519 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007014330

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR