BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4092388 · Received September 16, 2014

    Report

    Report Number
    9612164-2014-01206
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 19, 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 DEFORMED). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (OCCLUDED LESION). DEFORMATION ISSUE. EVALUATION CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (STENT DEFORMED). DEVICE FAILURE RELATED TO PATIENT CONDITION (OCCLUDED LESION). (B)(4).

    Description of Event or Problem · 1

    IT WAS INTENDED TO USE AN ENDEAVOR RESOLUTE DRUG ELUTING STENT TO TREAT AN OCCLUDED LESION IN THE LAD. THE DEVICE WAS PREPPED AND INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A NON-MEDTRONIC BALLOON BUT THE ENDEAVOR RESOLUTE DEVICE COULD NOT PASS THE LESION. THE DEVICE WAS REMOVED WITHOUT ISSUE AND DURING EXAMINATION IT WAS FOUND THAT THE MIDDLE OF THE STENT WAS DAMAGED. THE PHYSICIAN USED A NEW DEVICE TO COMPLETE THE SURGERY. NO REPORTED PATIENT COMPLICATIONS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY. THE DISTAL TIP WAS FLARED. THE DISTAL SHAFT WAS KINKED 4.2CM DISTAL TO THE GUIDEWIRE ENTRY PORT. A NUMBER OF STRUTS ON THE 15TH, 16TH AND 17TH PROXIMAL STENT SEGMENTS WERE RAISED AND 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
    573723 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006664652

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR