BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1940623 · Received December 22, 2010

    Report

    Report Number
    2953200-2010-02619
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 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): EVAL RESULTS: (ROOT CAUSE OF EVENT IS UNDETERMINED). (STENT THROMBOSIS).

    Description of Event or Problem · 1

    A 2.5MM DIAMETER X 08MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS DEPLOYED TO THE LAD 6-7. IN ADDITION, A COMPETITOR STENT WAS ALSO DEPLOYED. THERE WAS 90% STENOSIS PRIOR TO THE PROCEDURE AND 0% POST-PROCEDURE. PRE-DILATATION AND POST-DILATATION TOOK PLACE. AT AN UNK TIME AFTERWARDS, A SUB-ACUTE THROMBOSIS TOOK PLACE IN THE LAD 5-6. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001445222

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization