BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1884854 · Received October 15, 2010

    Report

    Report Number
    2953200-2010-01970
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, METHOD: FILM. RESULTS/CONCLUSIONS: FAILURE TO DELIVER STENT, STENT DEFORMATION. SEVERE CALCIFICATION. EVAL SUMMARY: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. A NUMBER OF STRUTS ON THE 6TH, 7TH AND 10TH PROXIMAL STENT SEGMENTS WERE DEFORMED. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE INNER SHAFT MARKERS AND BALLOON PILLOWS, AS PER SPECIFICATIONS. CD IMAGES WERE ALSO PROVIDED FOR EVAL. THE CD IMAGES CONFIRM THAT THE LESION WAS IN A SEVERELY CALCIFIED VESSEL.

    Description of Event or Problem · 1

    AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT, LENGTH 18MM, DIAMETER 2.5 MM, WAS INTENDED TO TREAT AN EXTREMELY CALCIFIED LCX LESION IN A PT. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO PASS THE LESION AND, ON REMOVAL FROM THE PT, THE STENT STRUTS WERE DAMAGED. THE LESION WAS PRE-DILATED PRIOR TO ATTEMPTED STENT PLACEMENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALITIES NOTED. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001151953

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK