BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2023323 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00062
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    December 25, 2010
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC IRELAND
    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

    (B)(4).

    Description of Event or Problem · 1

    PATIENT RECEIVED A 3.0MM DIAMETER X 12MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE PROX RCA DURING INDEX PROCEDURE AND A 2.5MM DIAMETER X 30MM LENGTH ENDEAVOR SPRINT RX STENT IN THE PROX CX DURING STAGED PROCEDURE WITH NO ISSUE REPORTED; HOWEVER, IT WAS REPORTED THAT, APPROXIMATELY 6 MONTHS POST PROCEDURE, THE PATIENT PRESENTED WITH MI SYMPTOMS. RE-HOSPITALIZATION WAS REQUIRED. ONE ENDEAVOR STENT WAS DEPLOYED TO 2ND OBTUSE MARGINAL. NO OTHER CLINICAL SEQUELAE WERE REPORTED. INVESTIGATOR REPORTED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY STENT AND WAS UNRELATED TO THE PROCEDURE. REF MFR REPORT NUMBER 9612164201100063.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000894548

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization CLOPIDOGREL| ASA