BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2133402 · Received June 14, 2011

    Report

    Report Number
    9612164-2011-00575
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 23, 2011
    Report Date
    June 22, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED). (MI).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENTS WERE SUCCESSFULLY DEPLOYED TO THE PROXIMAL AND MID LAD FOLLOWING PREDILATION. THE LESIONS WERE POST-DILATED AND THE OPERATION RESULTED IN 0% STENOSIS. ONE DAY POST INDEX PROCEDURE THE PT WAS DIAGNOSED WITH A NON Q-WAVE MI. IT WAS REPORTED TO BE NON-SEVERE. THE INVESTIGATOR REPORTS THAT THERE IS NO RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT/ZOTAROLIMUS BUT THE RELATIONSHIP TO THE PROCEDURE IS UNK. PT IS REPORTED TO HAVE RECOVERED. SUSTAINED VENTRICULAR TACHYCARDIA WAS OBSERVED 5 DAYS LATER. IT WAS NOT CONSIDERED AS MYOCARDIAL ISCHEMIA RELATED AND CONSERVATIVE MANAGEMENT WAS TAKEN. THE PT WAS DISCHARGED 2 WEEKS LATER. REFERENCE MFR REPORT NUMBER 9612164201100574.

    Description of Event or Problem · 1

    APPROXIMATELY 5 MONTHS 3 WEEKS POST INDEX PATIENT EXPERIENCED UNSTABLE ANGINA PECTORIS (UAP) WHICH WAS TREATED BY REVASCULARIZATION. APPROXIMATELY 6MONTHS 1 WEEK POST INDEX PROCEDURE UNDERWENT REVASCULARIZATION OF PROXIMAL LAD.

    Description of Event or Problem · 1

    THE PREVIOUS MI WHICH WAS REPORTED TO HAVE OCCURRED ONE DAY POST INDEX PROCEDURE, ACTUALLY OCCURRED ON THE DAY OF THE PROCEDURE. ADDITIONAL INFORMATION ALSO REPORTED THAT IVUS PERFORMED POST INDEX PROCEDURE INDICATED THAT THE STENTS WERE NOT COMPLETELY OPPOSED TO THE VESSEL WALL. HOWEVER, THE PHYSICIAN INDICATED THAT THE STENTS WERE SUCCESSFULLY DEPLOYED. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE, REVASCULARIZATION OF THE TARGET VESSEL WAS CARRIED OUT BY POBA TO TREAT IN-STENT RESTENOSIS OF A NON-MEDTRONIC STENT IMPLANTED IN THE LAD. PATIENT WAS REPORTED TO BE IN REMISSION POST REVASCULARIZATION. INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    APPROXIMATELY 46.5 MONTHS POST INDEX PROCEDURE THE PATIENT UNDERWENT TVR OF THE LAD WITH DES (NON-MDT) AND DEB (UNK BRAND) TO TREAT RESTENOSIS AND SILENT MYOCARDIAL ISCHEMIA. INVESTIGATOR INDICATED THAT THE EVENT WAS RELATED TO THE STUDY DEVICE. THE PATIENT IS IN REMISSION.

    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 74 YR Hospitalization| R CLOPIDOGREL| ASPIRIN