BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2201866 · Received August 5, 2011

    Report

    Report Number
    9612164-2011-00870
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    November 8, 2012
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: (CVA/STROKE, REVASCULARIZATION).

    Description of Event or Problem · 1

    THERE WERE THREE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS IMPLANTED DURING THE INDEX PROCEDURE; ONE IN THE PROXIMAL LAD, ONE IN THE MID LAD AND ONE IN THE MID RCA. AT 3 MONTH FOLLOW UP, PT'S WORST ANGINA STATUS WAS REPORTED AS II PER THE (B)(6) CRITERIA. A PCI REVASCULARIZATION WAS CARRIED OUT APPROX 4 MONTHS POST INDEX PROCEDURE. THREE OTHER BRAND STENTS WERE IMPLANTED IN THE PROXIMAL LAD TO TREAT IN-STENT RESTENOSIS. IT IS REPORTED THAT THE PT SUFFERED A STROKE APPROX 8 MONTHS POST PROCEDURE. INVESTIGATOR INDICATED THAT IT HAD REMOTE RELATIONSHIP TO THE STUDY DEVICE AND WAS NOT RELATED TO THE STUDY PROCEDURE. EVENT WAS REPORTED TO BE SEVERE IN INTENSITY. ACTION TAKEN WAS REPORTED AS THROMBOLYTIC THERAPY, CT SCAN AND REHAB. (REF MFR # 9612164-2011-00871 & 9612164-2011-00872).

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT SUFFERED A MYOCARDIAL INFRACTION ON THE SAME DAY AS THE PREVIOUSLY REPORTED CVA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PREVIOUSLY REPORTED REVASCULARIZATION EVENT THAT OCCURRED 4 MONTH POST INDEX WAS DEFINITELY RELATED TO THE STUDY DEVICE. IT WAS ALSO REPORTED THAT THE PREVIOUSLY REPORTED MI THAT OCCURRED 7.5 MONTHS POST INDEX WAS TREATED WITH MEDICATION AND WAS ASSESSED TO BE NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND A DIAGNOSTIC ANGIO WAS PERFORMED AND RECEIVED PCI. PATIENT RECEIVED ANOTHER BRAND STENT IN THE LAD. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT WAS ADMITTED WITH ANGINA PECTORIS AND A REVASCULARIZATION WAS CARRIED OUT APPROXIMATELY 14 MONTHS POST THE INDEX PROCEDURE DUE TO INSTENT RESTENOSIS OF THE PREVIOUSLY PLACED STENT IN THE MID LAD. THE PATIENT RECOVERED WITH TREATMENT. THE INVESTIGATOR HAS INDICATED THE EVENT WAS PROBABLY RELATED TO THE STUDY DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R ASPIRIN AND CLOPIDOGREL