BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2181373 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00800
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 29, 2012
    Report Date
    January 15, 2013
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (MYOCARDIAL INFARCTION & REVASCULARIZATION).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT RECEIVED REVASC PTCA WITH THE IMPLANTATION OF AN ENDEAVOR STENT IN THE LAD APPROXIMATELY 4 YEARS AND 3 MONTHS POST INDEX. IT WAS REPORTED THAT INDICATION FOR INTERVENTION WAS POSITIVE HISTORY OR RECURRENT ANGINA PECTORIS PRESUMABLY RELATED TO THE TARGET VESSEL. IT WAS NOT ASSESSED IF THIS EVENT WAS RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    THE PT HAD ONE ENDEAVOR RX DRUG ELUTING STENT IMPLANTED TO THE PROXIMAL LAD. THE NEXT DAY, DURING A PLANNED STAGED PROCEDURE, THE PT HAD ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT IMPLANTED TO THE 1ST OBTUSE MARGINAL. FOLLOWING REVIEW BY THE CLINICAL EVENTS COMMITTEE, IT IS REPORTED THAT A NON Q-WAVE MI OCCURRED ON THE SAME DAY. FOUR DAYS LATER, DURING A PLANNED STAGED PROCEDURE, THE PT HAD ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT IMPLANTED TO THE 1ST LEFT POSTEROLATERAL BRANCH. THE PT WAS ASYMPTOMATIC AT 30 DAY, 6 MONTH, 1 YEAR AND 1.5 YEAR F/U. ONE WEEK POST 1.5 YEAR F/U THE PT SUFFERED A NON Q-WAVE MI LOCATION OF THE INFARCTION WAS NON-DETERMINABLE. REVASCULARIZATION (PTCA) WAS PERFORMED ON THE SAME DAY WITH ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT IMPLANTED TO THE 2ND LEFT POSTEROLATERAL BRANCH. INDICATION FOR INTERVENTION WAS POSITIVE HISTORY OR RECURRENT ANGINA PECTORIS PRESUMABLY RELATED TO THE TARGET VESSEL. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY STENT. THE PT WAS TAKING CLOPIDOGREL & ASPIRIN 24 HRS PRIOR TO EVENT. (REF MFR # 9612164201100799 & 9612164201100801).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000396161

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention