BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 1040181 · Received May 8, 2008

    Report

    Report Number
    2953200-2008-00296
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 10, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (HEMORRHAGE REQUIRING TRANSFUSION). PATIENT'S CONDITION AFFECTED (SPONTANEOUS BLEED). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION. OTHER: EXTENDED HOSPITALIZATION.

    Description of Event or Problem · 1

    PATIENT SUFFERING FROM SILENT ISCHEMIA. ONE LESION IN THE PROXIMAL RCA WAS TREATED APPROXIMATELY 2 MONTHS AGO. ONE 3.50MM X 30MM ENDEAVOR STENT WAS IMPLANTED. EIGHTEEN DAYS POST IMPLANT THE PATIENT SUFFERED A SPONTANEOUS BLEED. THE INVESTIGATOR STATED THE LOCATION OF BLEED IS UNKNOWN. FFP TRANSFUSION REQUIRED. EVENT CAUSED AN EXTENDED HOSPITALIZATION. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000308436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization PATIENT WAS TAKING ASA & CLOPIDOGREL| TICLOPIDINE 24 HRS BEFORE THE EVENT