BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4112864 · Received September 24, 2014

    Report

    Report Number
    9612164-2014-01232
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    February 21, 2012
    Report Date
    January 13, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CEC ADJUDICATED THAT THE PATIENT SUFFERED A NON TARGET VESSEL MI (MDT AND ARC DEFINED) APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE. THE SITE REPORTED THAT THE PATIENT SUFFERED ANOTHER MI APPROXIMATELY 5 DAYS LATER. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS REMOTELY RELATED TO THE STUDY DEVICE. PATIENT IS REPORTED TO HAVE RECOVERED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED IN THE MID LCX. IT IS REPORTED THAT APPROXIMATELY 56 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED MYOCARDIAL INFARCTION. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT WAS TREATED WITH MEDICATION. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PREVIOUSLY REPORTED MYOCARDIAL INFARCTION EVENT OCCURRED 2 DAYS PRIOR TO THE DATE PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596175 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention