BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3951750 · Received July 23, 2014

    Report

    Report Number
    9612164-2014-00982
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 14, 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) ¿ 90% STENOSIS, CALCIFICATION AND TORTUOSITY. (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ 90% STENOSIS, CALCIFICATION AND 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 (3.00MM X 30MM) TO A CALCIFIED LESION IN THE LCX WITH 90% STENOSIS AND VESSEL TORTUOSITY BUT THE DEVICE COULD NOT CROSS. THE LESION HAD BEEN PRE-DILATED. THE PHYSICIAN REMOVED THE DEVICE AND GAVE UP THE SURGERY. THE PATIENT IS GOOD. IN THE FUTURE THE PHYSICIAN PLANS TO IMPLANT ANOTHER MODEL DEVICE IN THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DISTAL SHAFT WAS PINCHED/KINKED. THE DISTAL TIP WAS FLARED AND PINCHED INDICATING IT MAY HAVE BEEN STUBBED ON ADVANCEMENT TOWARDS THE TARGET LESION. NUMEROUS MIDDLE AND DISTAL STENT SEGMENTS WERE DEFORMED. 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
    429871 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007015797

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR