BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2080670 · Received April 26, 2011

    Report

    Report Number
    9612164-2011-00298
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    August 23, 2009
    Report Date
    March 29, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO ENDEAVOR RX DRUG-ELUTING STENTS WERE IMPLANTED IN THE PROX RCA DURING THE INDEX PROCEDURE. A BLEED AT THE PUNCTURE TYPE IS REPORTED TO HAVE OCCURRED ON THE SAME DAY AS THE INDEX PROCEDURE. PT WAS ASYMPTOMATIC AT THE 30 DAY, 6 MONTH AND 1 YEAR FOLLOW-UPS. APPROX 16 MONTHS POST INDEX PROCEDURE THE PT WAS ADMITTED TO HOSP WITH "AF AND SMALL TROP RISE. SPONTANEOUSLY REVERTED TO SR. CARDIOLOGIST FELT THAT HE HAD A TYPE II MI (SUPPLY AND DEMAND) RATHER THAN AN ACS. HE HAD A NEGATIVE ETT AT DISCHARGE." THE PT WAS TAKING ASPIRIN 24 HOURS BEFORE THE EVENT, THE INVESTIGATOR HAS STATED THAT THIS DID NOT INVOLVE THE TARGET LESION AND THE EVENT WAS NOT RELATED TO THE STUDY PROCEDURE. PT HAD CARDIAC STATUS OF UNSTABLE ANGINA AT THE 1.5 YEAR F/U, WAS ASYMPTOMATIC AT THE 2 YEAR F/U AND HAD CARDIAC STATUS OF STABLE ANGINA AT THE 2.5 YEAR F/U. APPROX 34 MONTHS POST INDEX PROCEDURE A REVASCULARIZATION OF THE PROX LAD WAS PERFORMED WITH ONE OTHER BRAND STENT AND ONE ENDEAVOR RESOLUTE STENT IMPLANTED. THE INVESTIGATOR HAS STATED THAT THIS WAS A NON-TARGET VESSEL AND THE EVENT WAS NOT RELATED TO THE STUDY STENTS OR PROCEDURE. PT WAS ASYMPTOMATIC AT THE 3 YEAR F/U. (REF MFR # 9612164-2011-00299).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization ASPIRIN