BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4820518 · Received June 5, 2015

    Report

    Report Number
    9612164-2015-00893
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    April 17, 2015
    Report Date
    May 8, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: RELATED TO OPERATIONAL CONTEXT (ROOT CAUSE MOST LIKELY RELATED TO THE ATTEMPTED USE OF THE DEVICE IN A SEVERELY CALCIFIED, CTO LESION). INHERENT RISK OF PROCEDURE (STENT EMBOLISM). CONCLUSIONS: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT (ROOT CAUSE MOST LIKELY RELATED TO THE ATTEMPTED USE OF THE DEVICE IN A SEVERELY CALCIFIED, CTO LESION). KNOWN INHERENT RISK OF A PROCEDURE (STENT EMBOLISM) (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER ONE ENDEAVOR RESOLUTE (RX) DRUG-ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION IN THE LAD. THE ANGIO RESULT SHOWED CHRONIC TOTAL OCCLUSION IN THE PROXIMAL LAD. THE DEVICE WAS INSPECTED AND PREPPED PRIOR TO USE AS PER IFU WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE STENT DISLODGED DURING THE PROCEDURE. THE STENT WAS DELIVERED BY 'SPOON CRUSH' METHOD TO THE RADIAL ARTERY AND WAS EXPANDED THERE. THE PHYSICIAN USED A NEW STENT TO TREAT THE LESION. IT WAS REPORTED THAT THE OPERATOR CONSIDERED THE CALCIFICATION WAS 'TOO SERIOUS' AND CAUSED THE STENT DISLODGEMENT. PATIENT STATUS IS GOOD. NO FURTHER CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE DISTAL TIP OF THE DEVICE WAS FLARED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN PASSING A 0.015 INCH MANDREL ALONG THE INNER LUMEN. THE STENT WAS NOT RETURNED WITH THE DEVICE HOWEVER CRIMP IMPRESSIONS WERE VISIBLE ON THE BALLOON. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED PRODUCT (RESOLUTE INTEGRITY). THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365745 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007108538

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention