BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1864502 · Received October 6, 2010

    Report

    Report Number
    2953200-2010-01891
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    October 13, 2009
    Report Date
    September 6, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - PERFORATION CAUSED BY ANOTHER DEVICE USED IN THE PROCEDURE; VESSEL PERFORATION. CONCLUSIONS - PERFORATION CAUSED BY ANOTHER DEVICE USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3.0MM DIAMETER X 30MM LENGTH ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT A CASS#1-2, RESULTING IN 0% STENOSIS. PRE-DILATATION WAS PERFORMED WITH A 3.5MM DIAMETER X 15MM LENGTH BALLOON AT 20 ATM. NO ABNORMALITIES WERE NOTED DURING THE STENT DEPLOYMENT. DURING THE PROCEDURE, A CORONARY ARTERY VESSEL PERFORATION OCCURRED. A BALLOON WAS USED TO STOP THE BLEEDING. THE ACCOUNT REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT WAS RELATED TO THE PCI PROCEDURE. THE PATIENT RECOVERED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention CLOPIDOGREL| ASPIRIN