BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 5754446 · Received June 28, 2016

    Report

    Report Number
    9612164-2016-00622
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    May 17, 2016
    Report Date
    May 31, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE IS NO DAMAGE TO THE DISTAL TIP OF THE DEVICE. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE INNER SHAFT MARKERS AS PER SPECIFICATION REQUIREMENT. THE 10TH DISTAL STENT SEGMENT WAS MISALIGNED AND DEFORMED WITH RAISED STRUTS. STENT OD¿S: PROXIMAL STENT OD IS 0.045INCH. 10TH DISTAL SEGMENT OD IS 0.056INCH. DISTAL STENT OD IS 0.045INCH. SPECIFICATION IS 0.055 INCH MAX. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE TWO ENDEAVOR RESOLUTE DRUG ELUTING STENTS TO TREAT A PATIENT. THE LESION WAS SITUATED IN THE LAD AND EXHIBITED 90% OCCLUSION, CALCIFICATION AND NORMAL TORTUOSITY. BOTH DEVICES WERE REMOVED FROM THEIR PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE TARGET LESION WAS PRE-DILATED USING A EUPHORA BALLOON CATHETER PRIOR TO DELIVERY OF THE ENDEAVOR RESOLUTE DEVICES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT BOTH DEVICES FAILED TO CROSS THE TARGET LESION. NO PATIENT INJURY REPORTED. THE PHYSICIAN DID NOT COMPLETE THE PROCEDURE. 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
    409240 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007858764

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR