BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2100445 · Received May 17, 2011

    Report

    Report Number
    9612164-2011-00435
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    November 25, 2010
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (MI).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD DURING INDEX PROCEDURE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY F/U. PT'S CURRENT CARDIAC STATUS AT 6 MONTH, 1.5 YEAR AND 2 YEAR FOLLOW-UPS WAS STABLE ANGINA. IT IS REPORTED THAT THERE WAS A REVASCULARIZATION CARRIED OUT APPROX 34 MONTHS POST INDEX PROCEDURE. THERE WAS AN ENDEAVOR STENT IMPLANTED IN THE 1ST OBTUSE MARGINAL AND THERE WAS A BALLOON ONLY REVASCULARIZATION OF THE PROXIMAL LAD CARRIED OUT. THE PT SUFFERED AN ACUTE NON-STEMI APPROX ONE DAY LATER. IT IS REPORTED THAT IT WAS A NON-Q-WAVE MI, LOCATED IN THE LATERAL, NOT INVOLVING THE TARGET LESION. THE PT DID NOT FEEL ANY DISCOMFORT AND COULD BE DISCHARGED AFTER IMPROVEMENT OF CARDIAC ENZYMES ONE DAY LATER. PT'S CURRENT CARDIAC STATUS AT 3 YEAR F/U WAS STABLE ANGINA. (REF MFR # 9612164-2011-00434).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization ASPIRIN