BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 1032146 · Received April 21, 2008

    Report

    Report Number
    2953200-2008-00235
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 28, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PT HAD BEEN TREATED FOR HYPERCHOLESTEROLEMIA. ONE LESION WAS TREATED 25 MONTHS AGO. MEDICATIONS PRESCRIBED AT THE DAY OF PROCEDURE WERE AS FOLLOWS: ASPIRIN = 100 MG; CLOPIDOGREL = 75 MG. THE LESION TREATED WAS LOCATED IN THE MID-LAD. ONE ENDEAVOR STENT WAS SUCCESSFULLY IMPLANTED (2.25 X 30 MM STENT). AT 24 MONTHS POST IMPLANT, A REPEAT REVASCULARIZATION WAS PERFORMED ON THE PROXIMAL LAD (PTCA, UNK STENT BRAND). INDICATION FOR REVASCULARIZATION WAS STABLE ANGINA. PT WAS SENT HOME ON THE SAME DAY FOLLOWING PTCA. PT DEVELOPED SUDDEN ANGINA AND AN AMBULANCE WAS CALLED. IMMEDIATE REVASCULARIZATION WAS PERFORMED ON THE NEXT DAY. THE INDICATION FOR REVASCULARIZATION WAS A SUSPECTED STENT THROMBOSIS. AT THE 24 MONTH FOLLOW-UP STAGE, THE PT WAS ASYMPTOMATIC. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE US; HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED PROD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention