BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2052170 · Received March 1, 2011

    Report

    Report Number
    9612164-2011-00004
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (DOCTOR'S ATTEMPTED DIRECT STENTING OF 80% STENOSED LESION), (STENT DEFORMATION AND FAILURE TO DELIVER DEVICE), (DIRECT LESION STENTING). EVAL: CONCLUSION: LACK OF EFFECTIVENESS RELATED TO PT CONDITION (DOCTOR'S ATTEMPTED DIRECT STENTING OF 80% STENOSED LESION), (DIRECT LESION STENTING). EVAL SUMMARY: A NUMBER OF STENT SEGMENTS ALONG THE STENT WERE DISTURBED. THE 14TH DISTAL STENT SEGMENT WAS RAISED, DEFORMED AND STRETCHED DISTALLY. THE DISTAL TIP WAS SLIGHTLY FRAYED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.50 MM DIAMETER X 24MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN A PT. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO DIRECT STENT THE LESION, WHICH EXHIBITED 80% STENOSIS, AND REMOVED THE DEVICE FROM THE PT. AFTER PRE-DILATATION OF THE LESION, THE PHYSICIAN ATTEMPTED TO RE-INSERT THE STENT BUT NOTICED THE DAMAGE. THE LESION WAS SUCCESSFULLY TREATED WITH ANOTHER STENT AFTER THE PRE-DILATATION ACTIVITIES. 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 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 CARDIOVASCULAR GALWAY NA 0001029297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK