BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3952819 · Received July 23, 2014

    Report

    Report Number
    9612164-2014-00987
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    April 14, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). PATIENT CONDITION AFFECTED EFFECTIVENESS OF THE DEVICE (THE LESION HAD MODERATE TORTUOSITY AND MODERATE CALCIFICATION). DEFORMATION PROBLEM. EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION DEVICE (THE LESION HAD MODERATE TORTUOSITY AND MODERATE CALCIFICATION). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DEPLOY AN ENDEAVOR RESOLUTE DRUG ELUTING STENT. THE TARGET LESION WAS IN THE MID RCA. THE LESION HAD MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE LESION WAS PRE-DILATED WITH A 2.0X12MM BALLOON. THE STENT WAS UNABLE TO CROSS THE LESION AND THE STENT BECAME DEFORMED. PHYSICIAN FEELS DAMAGE WAS DUE TO DIFFICULT LESION MORPHOLOGY. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATION: THE STENT HAD MOVED DISTALLY COVERING THE DISTAL MARKER BAND AND PARTIALLY COVERING THE DISTAL TIP. THE 4TH TO 7TH PROXIMAL STENT SEGMENTS WERE RAISED AND DEFORMED. CRIMP IMPRESSIONS WERE VISIBLE ON THE BALLOON. ¿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
    430438 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND ERES30015X 0006878484

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR