BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3922835 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00771
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 11, 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: RELATED TO OPERATIONAL CONTEXT ¿ STENT DAMAGE IS MOST LIKELY PROCEDURAL RELATED. INHERENT RISK OF PROCEDURE¿ FAILURE TO DELIVER STENT AND STENT DEFORMATION. (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: RELATED TO OPERATIONAL CONTEXT) ¿ STENT DAMAGE IS MOST LIKELY PROCEDURAL RELATED. INHERENT RISK OF PROCEDURE¿ FAILURE TO DELIVER STENT AND STENT DEFORMATION. (B)(4) .

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO IMPLANT ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT (3.00MM X 18MM) IN THE LCX BUT THE STENT BENT WHEN ATTEMPTING TO DELIVER. PHYSICIAN HAD DILATED THE LESION WITH BALLOON. DOCTOR CHANGED ANOTHER STENT TO COMPLETE THE SURGERY. THE PATIENT IS WELL NOW. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 8TH AND 9TH PROXIMAL SEGMENTS WERE RAISED AND DEFORMED. THE DISTAL TIP WAS DAMAGED. 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
    400005 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006732471

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR