BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1844665 · Received September 23, 2010

    Report

    Report Number
    2953200-2010-01808
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 24, 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: (PATIENT CEASED TO TAKE PRESCRIBED DUAL-ANTIPLATELET MEDICATION, (STENT THROMBOSIS). CONCLUSIONS: (PATIENT CEASED TO TAKE PRESCRIBED DUAL-ANTIPLATELET MEDICATION). LITERATURE SOURCE ADDRESS: HTTP://WWW.CVIT2010.JP/PRAGRAM/.

    Description of Event or Problem · 1

    THE SOURCE LITERATURE REPORTED THAT THE PHYSICIAN SUCCESSFULLY IMPLANTED AN ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO LAD # 6. THE PATIENT DISCONTINUED TAKING THE PRESCRIBED ANTI-PLATELET MEDICATION POST STENT DEPLOYMENT. AN ANGIOGRAM CONFIRMED STENT THROMBOSIS AT LAD # 6. AFTER ASPIRATION AND THROMBOLYSIS, THE LESION WAS DILATED AND A 2.5MM DIAMETER X 12MM LENGTH ENDEAVOR RX WAS DEPLOYED. THE PHYSICIAN REPORTED THAT THE THROMBOSIS WAS NOT CAUSED BY THE DES. 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 60 YR Hospitalization