BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2192817 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00770
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    9060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DISLODGE AND FAILURE TO DELIVER STENT. RESULTS/CONCLUSIONS: PT LESION/VESSEL MORPHOLOGY: 90% STENOSIS AND SEVERE CALCIFICATION.

    Description of Event or Problem · 1

    THE PHYSICIAN DEPLOYED A 3.5MM DIAMETER X 15MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANCE (RX) DRUG ELUTING STENT TO TREAT A LESION IN A PT WITH 90% STENOSIS AND SEVERE CALCIFICATION. IT WAS REPORTED THAT DURING THE SURGERY PROCEDURE, THE STENT DISLODGED FROM THE BALLOON AND REMAINED IN THE PT. NO PT INJURY OCCURRED AND NO CLINCIAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005462758

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK