BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3890166 · Received June 24, 2014

    Report

    Report Number
    9612164-2014-00667
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 28, 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 ¿ 98% STENOSIS AND TORTUOSITY). (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY ¿ 98% STENOSIS AND TORTUOSITY). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER 2 ENDEAVOR RESOLUTE STENTS (2.25MM X 14MM AND 2.25MM X 24MM) TO A LESION IN THE RCA WITH 98% STENOSIS WITH VESSEL TORTUOSITY BUT RESISTANCE WAS NOTED AND WHEN THE DEVICES WERE REMOVED IT WAS NOTED THAT THEY WERE DEFORMED. THE PHYSICIAN CHANGED TO ANOTHER STENT TO COMPLETE THE SURGERY. THE PATIENT IS GOOD. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: MULTIPLE STRUTS FROM THE 7TH AND 8TH PROXIMAL STENT SEGMENTS WERE RAISED, DEFORMED AND PULLED PROXIMALLY. THERE WAS GREATER SEPARATION BETWEEN THE 6TH AND 7TH PROXIMAL STENT SEGMENT, CAUSING THE DISTAL END OF THE STENT TO OVERLAP WITH THE DISTAL MARKER BAND. THE DISTAL TIP WAS FLARED. THE GUIDEWIRE ENTRY PORT WAS SLIGHTLY TORN. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE RX) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY RX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368293 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006249313

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR