BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1211069 · Received October 24, 2008

    Report

    Report Number
    2953200-2008-00958
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    January 21, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (THROMBOSIS). SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED (2.75 X 18MM) IN THE PROXIMAL LAD, 3 ENDEAVOR SPRINT DRUG-ELUTING STENTS (3.5 X 15MM, 3.5 X 15MM & 3.00 X 18MM) STENTS WERE IMPLANTED IN THE MID LAD AND 1 ENDEAVOR SPRINT DRUG-ELUTING STENT (3.5 X15MM) WAS IMPLANTED IN THE PROXIMAL LAD. (MFR REPORT# 2953200-2008-00958 - 00962) STENT THROMBOSIS OF THE MID LAD WAS REPORTED LATER THAT DAY. THE INVESTIGATOR HAS INDICATED THAT AN ANGIOGRAPHY WAS PERFORMED, WHICH DID NOT SHOW THROMBOSIS OF A STUDY STENT. IT IS REPORTED THAT REVASCULARIZATION WAS PERFORMED AS A RESULT OF THIS EVENT. THERE WAS THE NEED FOR STENT IMPLANTATION BECAUSE OF STENT THROMBOSIS. A PTCA REVASCULARIZATION OF THE DISTAL LAD WAS REPORTED TO HAVE OCCURRED. ONE DRUG-ELUTING STENT FROM ANOTHER MFR WAS SUCCESSFULLY IMPLANTED (2.75 X 23MM). INVESTIGATOR HAS INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT 30 DAY AND 6 MONTH FOLLOW UP. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000520215

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention