BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 2141103 · Received June 21, 2011

    Report

    Report Number
    9612164-2011-00614
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    August 15, 2008
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: MI, STENT THROMBOSIS, TVR.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE TWO ENDEAVOR MX DRUG ELUTING STENTS WERE IMPLANTED AT THE 1ST DIAGONAL BRANCH. ONE ENDEAVOR MX DRUG ELUTING STENT WAS IMPLANTED AT THE MID LAD. IT WAS REPORTED THAT AN MI OCCURRED 1 DAY POST STENT IMPLANT. MI WAS CATEGORIZED AS A NON Q WAVE MI, IN THE TERRITORY OF THE TARGET VESSEL. NO FURTHER DETAILS ARE AVAILABLE. EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. BALLOON REVASCULARIZATION OF THE MID LAD WAS CARRIED OUT 7 DAYS POST THE INDEX PROCEDURE. APPROXIMATELY 11 DAYS POST INDEX PROCEDURE A STENT THROMBOSIS EVENT (ANGIOGRAPHICALLY PROVEN) IS REPORTED TO HAVE OCCURRED. EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH A STENT THROMBOSIS. NO FURTHER DETAILS ARE AVAILABLE. A REVASCULARIZATION OF THE MID LAD WAS CARRIED OUT 11 DAYS FOLLOWING INDEX PROCEDURE. ONE OTHER BRAND STENT WAS IMPLANTED. A REVASCULARIZATION OF THE 1ST DIAGONAL BRANCH WAS ALSO CARRIED OUT ON THE SAME DAY. ONE OTHER BRAND STENT WAS IMPLANTED. INVESTIGATOR HAS INDICATED THAT EVENTS WERE NOT RELATED TO THE STUDY STENT. PATIENT DISPLAYED STABLE ANGINA AT 30 DAY FOLLOW UP. PATIENT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 6 MONTH TO 2.5 YEAR FOLLOW UP. APPROXIMATELY 2.5 YEARS POST THE INDEX PROCEDURE REVASCULARIZATION OF THE MID LAD WAS CARRIED OUT, ONE COMPETITOR STENT WAS IMPLANTED. INVESTIGATOR HAS INDICATED THAT IS WAS NOT ASSESSABLE TO DETERMINE IF THE EVENT WAS RELATED TO THE STUDY STENT. (REF MFR # 9612164-2011-00615 & 9612164-2011-00616).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR CLOPIDOGREL| ASPIRIN