BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4091242 · Received September 16, 2014

    Report

    Report Number
    9612164-2014-01203
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    June 20, 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 (EMBOLIZATION). PATIENT CONDITION AFFECTED EFFECTIVENESS OF DEVICE (HIGHLY CALCIFIED LESION). DEFORMATION PROBLEM (STENT). EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (EMBOLIZATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (HIGHLY CALCIFIED LESION). (B)(4).

    Description of Event or Problem · 1

    EVENT DESCRIPTION: DURING AN ATTEMPT TO TREAT A LESION IN THE LAD ARTERY WITH 80-90% STENOSIS USING ENDEAVOR RESOLUTE DRUG ELUTING STENT; PHYSICIAN NOTED THE DEVICE COULD NOT CROSS THE LESION. THE LESION WAS PRE DILATED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE DISTAL TIP WAS SLIGHTLY FLARED INDICATING THAT IT WAS STUBBED ON ADVANCEMENT TOWARDS THE TARGET LESION. MULTIPLE STRUTS FROM THE 10TH, 11TH AND 12TH DISTAL STENT SEGMENTS WERE RAISED AND DEFORMED. THE PROXIMAL STENT OD WAS 0.047¿, THE MIDDLE STENT OD WAS 0.077¿ AND THE DISTAL STENT OD WAS 0.049¿. THE MAX STENT OD ACCORDING TO THE ENDEAVOUR RESOLUTE SPEC BOARD IS 0.055¿ MAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573336 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006654603

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR