BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2062047 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00085
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: PT VESSEL/LESION MORPHOLOGY. STENT DEFORMATION AND FAILURE TO DELIVER DEVICE. STENT. EVAL, CONCLUSION: PT VESSEL/LESION MORPHOLOGY. EVAL SUMMARY: A NUMBER OF STRUTS ON THE 10TH PROXIMAL STENT SEGMENT WERE RAISED AND STRETCHED DISTALLY.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.50 MM DIAMETER X 18MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN A PT. THE PT WAS REPORTED TO HAVE DIFFUSE DISEASE IN THE LCX AND THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT DEPLOYING A STENT AT THE LESION SITE. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE U.S 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 0004183362

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK