BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 2954810 · Received February 11, 2013

    Report

    Report Number
    9612164-2013-00162
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 14, 2013
    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 - (DEFORMATION AND FAILURE TO DELIVER THE STENT). (RELATED TO OPERATIONAL CONTEXT) ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED. (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE - (DEFORMATION AND FAILURE TO DELIVER THE STENT). (RELATED TO OPERATIONAL CONTEXT). ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DEPLOY 1 ENDEAVOR RESOLUTE DRUG ELUTING STENT TO A LESION BUT THE STENT COULD NOT CROSS, AFTER SEVERAL ATTEMPTS THE STENT WAS REMOVED AND DEFORMATION WAS NOTED ON THE STENT. ANOTHER STENT WAS IMPLANTED TO TREAT THE PATIENT. EVALUATION SUMMARY: THE DISTAL TIP WAS SLIGHTLY FLARED. A NUMBER OF STRUTS ON THE 1ST AND 4TH DISTAL SEGMENTS WERE RAISED AND DEFORMED. 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
    58701 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006422342

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR