BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4100572 · Received September 19, 2014

    Report

    Report Number
    9612164-2014-01217
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    June 30, 2014
    Report Date
    August 23, 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 WITH 90% STENOSIS). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). CONCLUSION RESULTS: DEVICE FAILURE RELATED TO PATIENT CONDITION (LESION WITH 90% STENOSIS). KNOWN INHERENT RISK OF A PROCEDURE (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT A LESION IN THE RCA EXHIBITING 90% STENOSIS USING A ENDEAVOR RESOLUTE (RX) DRUG ELUTING STENT. DEVICE WAS PREPPED PRIOR TO USE. DURING THE SURGERY, THE LESION WAS PRE-DILATED, BUT THE DEVICE FAILED TO CROSS THE TARGET LESION. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE 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: THE DISTAL TIP WAS FLARED. A NUMBER OF STRUTS ON THE 1ST AND 2ND PROXIMAL STENT SEGMENTS WERE RAISED AND DEFORMED. THE 6TH, 7TH, 12TH, 13TH AND 17TH PROXIMAL SEGMENTS WERE PARTIALLY DEFORMED. 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
    582749 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006754672

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR