BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4230717 · Received November 6, 2014

    Report

    Report Number
    9612164-2014-01432
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    August 6, 2014
    Report Date
    October 8, 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: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY - 88% STENOSIS). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). DEFORMATION PROBLEM (STENT DEFORMED). EVALUATION CONCLUSIONS: DEVICE FAILURE RELATED TO PATIENT CONDITION (LESION MORPHOLOGY - 88% STENOSIS). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    IT WAS ATTEMPTED TO TREAT A LESION EXHIBITING 99% STENOSIS IN THE RCA WITH AN ENDEAVOR RESOLUTE DRUG ELUTING STENT. THE LESION WAS FIRST PRE-DILATED WITH A 2.0X15MM BALLOON AND 88% STENOSIS REMAINED POST DILATATION. THE ENDEAVOR RESOLUTE DEVICE HAD BEEN INSPECTED AND PREPPED PRIOR TO USE WITHOUT ISSUE. IT WAS REPORTED THAT THE ENDEAVOR RESOLUTE STENT COULD NOT CROSS THE LESION DUE TO THE LEVEL OF CALCIFICATION PRESENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY AND THROUGH ANALYSIS OF THE RETURNED DEVICE THE STENT WAS OBSERVED TO BE DAMAGED. EVALUATION SUMMARY: THERE WERE TWO KINKS LOCATED ON THE DELIVERY SYSTEM, AT 12CM AND 60CM DISTAL TO THE STRAIN RELIEF. THE FIRST THREE DISTAL SEGMENTS OF THE STENT HAD EVIDENCE OF RAISED AND STRETCHED STRUTS. THE PROXIMAL SEGMENTS OF THE STENT HAD EVIDENCE OF STRETCHING AND MISALIGNMENT. 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
    714360 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006378085

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR