BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1920034 · Received December 3, 2010

    Report

    Report Number
    2953200-2010-02380
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    December 1, 2008
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: MYOCARDIAL INFARCTION AND REVASCULARIZATION.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT (3.00 X 24MM) WAS IMPLANTED TO THE PROXIMAL LAD. PT HAD CARDIAC STATUS OF STABLE ANGINA AT 30 DAY FOLLOW-UP. ON DAY OF 6 MONTH FOLLOW-UP, PT WAS ADMITTED FOR REPEAT DIAGNOSTIC ANGIOGRAM FOR ONGOING ANGINA SYMPTOMS. ON SAME DAY, A REVASCULARIZATION OF PROXIMAL LAD WAS PERFORMED. THERE WAS AN OTHER BRAND STENT IMPLANTED IN THE PROXIMAL LAD. INVESTIGATOR CLASSIFIED LESION AS RESTENOSIS OF TARGET LESION AFTER PREVIOUS PTCA. INVESTIGATOR STATED THAT EVENT WAS RELATED TO STUDY STENT AND STUDY PROCEDURE. PT HAD CARDIAC STATUS OF STABLE ANGINA AT 1 YEAR AND 1.5 YEAR FOLLOW-UP'S. AT 2 YEAR FOLLOW UP, PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. IT WAS REPORTED THAT THE PT SUFFERED AN MI APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE. A CABG REVASCULARIZATION AT THE PROXIMAL LAD, RIGHT POSTERIOR DESCENDING ARTERY AND THE 1ST OBTUSE MARGINAL IS ALSO REPORTED TO HAVE OCCURRED APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR SANTA ROSA NA 0000506867

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention