BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2160586 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00670
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    March 31, 2012
    Report Date
    August 22, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (DISSECTION).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT SUFFERED A MYOCARDIAL INFRACTION APPROXIMATELY 13 MONTHS POST THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT SUFFERED A MYOCARDIAL INFARCTION APPROXIMATLEY 4 MONTHS POST THE INDEX PROCEDURE. REF MFR# 9612164-2 011-00670, 9612164-2011-00671, 9612164-2012-00230.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A CABG REVASCULARIZATION WAS CARRIED OUT DUE TO THE PREVIOUSLY REPORTED MI OCCURRING 13 MONTHS POST INDEX PROCEDURE. THE INVESTIGATOR HAS REPORTED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    THE INVESTIGATOR HAS INDICATED THE MYOCARDIAL INFRACTION WAS PROBABLY RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT BALLOON ANGIOPLASTY WAS ALSO CARRIED OUT DUE TO THE PREVIOUSLY REPORTED MI OCCURRING 13 MONTHS POST INDEX PROCEDURE. IT WAS ALSO STATED THAT ONE OF THE STENTS IMPLANTED DURING THE INDEX PROCEDURE WAS IMPLANTED IN THE CX AND NOT THE LAD AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    EVENT DATE OF PREVIOUSLY REPORTED CABG SURGERY WAS PROVIDED.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENTS WERE IMPLANTED IN THE PROXIMAL LAD DURING THE INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED WITH ANGINA APPROXIMATELY 6 WEEKS POST INDEX PROCEDURE. THE PATIENT HAD AN ANGIOGRAM PERFORMED WHICH INDICATED 60-70 PERCENT HAZY STENOSIS AT THE PROXIMAL EDGE OF THE STENT. IT WAS ALSO REPORTED THAT A DISSECTION HAD OCCURRED POST INDEX PROCEDURE. AN ADDITIONAL ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS DEPLOYED IN THE PROXIMAL LAD WITH EXCELLENT RESULTS. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT REPEAT REVASCULARIZATION DUE TO RESTENOSIS. ADDITIONAL STENTS WERE PLACED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. REFERENCE MFR REPORT NUMBER 9612164-2011-00671.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R ASPIRIN| CLOPIDOGREL