BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 1090884 · Received August 1, 2008

    Report

    Report Number
    2953200-2008-00630
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    AN UNK SIZE ENDEAVOR RESOLUTE RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN UNK LESION. LESION MORPHOLOGY WAS REPORTED TO BE SEVERLY TORTUOUS. IT IS UNK IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE STENT CAME OFF IN THE LAD. THE STENT WAS CRUSHED INTO THE VESSEL WALL. THE PT IS REPORTED TO BE FINE. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE/LOT NUMBER UNK) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT ENDEAVOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention