BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 1031174 · Received April 18, 2008

    Report

    Report Number
    2953200-2008-00230
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    October 31, 2007
    Report Date
    February 13, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS- INHERENT RISK OF PROCEDURE (BYPASS SURGERY/STROKE/CAGB).CONCLUSION - OTHER, (LACK OF INFO).

    Description of Event or Problem · 1

    PT HAD BEEN TREATED FOR HYPERTENSION & HYPERCHOLESTEROLEMIA. TWO LESIONS WAS TREATED 23 MONTHS AGO. MEDICATIONS PRESCRIBED AT THE DAY OF PROCEDURE WERE AS FOLLOWS: ASPIRIN - 200MG; CLOPIDOGREL - 300MG. THE FIRST LESION TREATED WAS LOCATED IN THE PROXIMAL LAD. ONE ENDEAVOR STENT WAS SUCCESSFULLY IMPLANTED (3.0X15MM STENT). THE SECOND LESION TREATED WAS LOCATED IN THE MID LCX. ONE ENDEAVOR STENT WAS SUCCESSFULLY IMPLANTED (2.75X12MM STENT). (MDR 2953200-2008-00231) TICLOPIDINE WAS STOPPED ON 3 MONTHS POST PROCEDURE. AT 24 MONTH FOLLOW UP, IT WAS REPORTED THAT REVASCULARIZATION WAS PERFORMED 3 MONTHS AGO (CABG). THE INDICATION FOR REVASCULARIZATION WAS STABLE ANGINA. THE LOCATION OF THE REVASCULARIZATION WAS THE LAD AND LCX VESSEL. BOTH LESIONS/VESSELS HAD BEEN PRETREATED WITH ENDEAVOR STENTS. THE INVESTIGATOR STATED THAT THE RELATIONSHIP OF THE REVASCULARIZATION EVENT TO THE ENDEAVOR DEVICE WAS POSSIBLE/PROBABLE. FOLLOWING CABG THAT PT HAD ISCHEMIC CVA IN THE POST OPERATIVE PERIOD. THERE IS NO INFO AVAILABLE ABOUT CT REPORT OR SEQUELAE. IT WAS REPORTED THAT THE RELATIONSHIP OF THE STROKE EVENT TO THE ENDEAVOR DEVICE WAS POSSIBLE/PROBABLE. THE STROKE EVENT DID NOT LEAD TO THE PT'S DEATH. THE PT WAS ASYMPTOMATIC AT THE 24 MONTH FOLLOW-UP STAGE. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    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 53 YR Required Intervention