BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 3161320 · Received June 11, 2013

    Report

    Report Number
    9612164-2013-00632
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    February 18, 2011
    Report Date
    April 18, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSIONS: (MYOCARDIAL INFARCTION). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS A HISTORY OF HYPERLIPIDEMIA. INDEX PROCEDURE WAS PROMTED BY UNSTABLE ANGINA. THE PREVIOUSLY REPORTED REVASC OF THE LAD TOOK PLACE ONE DAY LATER THAN PREVIOUSLY REPORTED. THE PATIENT SUFFERED UNSTABLE ANGINA AND NOT MIS AS PREVIOUSLY REPORTED. THE PREVIOUSLY REPORTED REVASC WHICH WAS PERFORMED 19 MONTHS POST INDEX PROCEDURE WAS CARRIED OUT TO TREAT UNSTABLE ANGINA AND RESTENOSIS. IT IS REPORTED THAT THE PATIENT WAS TREATED WITH AN UNKNOWN DES DEVICE AND BALLOONING DURING PREVIOUSLY REPORTED TARGET LESION REVASCULARIZATION APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PREVIOUSLY REPORTED MI WHICH OCCURRED APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE OCCURRED ON A DATE 18 DAYS LATER THAN PREVIOUSLY REPORTED. IT IS REPORTED THAT THE PATIENT WAS TREATED WITH A BMS AND POBA DEVICE DURING PREVIOUSLY REPORTED TARGET LESION REVASCULARIZATION APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE. IT IS INDICATED THAT THE MI WHICH WAS PREVIOUSLY REPORTED TO HAVE OCCURRED 16 MONTHS POST INDEX PROCEDURE, OCCURRED APPROXIMATELY 19 MONTHS POST PROCEDURE.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR DRUG ELUTING STENT IMPLANTED IN THE LAD. IT IS REPORTED THAT APPROX. 4 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED RESTENOSIS AND HAD ONE NON-MEDTRONIC STENT IMPLANTED IN THE LAD. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THE PATIENT WAS IN REMISSION. IT IS REPORTED THAT 12 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A MI RELATED TO THE TARGET VESSEL OF THE LAD. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED. IT IS REPORTED THAT APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD A TARGET VESSEL REVASCULARIZATION OF THE LAD DUE TO RESTENOSIS USING AN UNKNOWN BARE METAL STENT. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED. IT IS REPORTED THAT APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED A MI OF THE TARGET VESSEL (THE LAD). THE EVENT WAS NOT ASSESSED FOR RELATEDNESS TO DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED. IT IS REPORTED THAT APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD A CABG REVASCULARIZATION OF THE LAD. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263295 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention