BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1665650 · Received April 21, 2010

    Report

    Report Number
    2953200-2010-00679
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    December 1, 2009
    Report Date
    March 22, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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): EVALUATION RESULTS: REVASCULARIZATION, MI, DEATH.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RX DRUG ELUTING CORONARY STENTS WERE DEPLOYED IN A PATIENT TO TREAT A LESION LOCATED IN THE PROXIMAL RCA (MFR REPORT # 2953200-2010-00678, 2953200-2010-00679). PATIENT'S CARDIAC STATUS AT TIME OF PROCEDURE WAS STABLE ANGINA. A REVASCULARIZATION OF THE PROXIMAL RCA WAS CARRIED OUT APPROXIMATELY 2 MONTHS FOLLOWING INDEX PROCEDURE, DUE TO RE-STENOSIS AFTER PREVIOUS PTCA. A REVASCULARIZATION OF THE 1ST OBTUSE MARGINAL WAS ALSO CARRIED OUT ON THE SAME DAY. TWO ENDEAVOR SPRINT RX DRUG-ELUTING CORONARY STENT WERE IMPLANTED (MFR REPORT # 2953200-2010-00680, 2953200-2010-00681). AT 6 MONTH FOLLOW UP, PATIENT DISPLAYED STABLE ANGINA. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD AN ACUTE NON-STEMI. PTCA REVASCULARIZATION WAS PERFORMED. INVESTIGATOR HAS INDICATED THAT THE TARGET LESION WAS INVOLVED. IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY 17 MONTHS FOLLOWING INDEX PROCEDURE. CAUSE OF DEATH WAS ISCHEMIC HEART DISEASE RELATED TO ATHEROSCLEROSIS. AN AUTOSPY WAS PERFORMED WHICH NOTED PATENT STENT IN THE LEFT CIRCUMFLEX. AN OCCLUSION OF THE RIGHT CORONARY ARTERY WAS NOTED. INVESTIGATOR REPORTED THAT THE EVENT WAS RELATED TO THE STUDY STENT. INVESTIGATOR REPORTED THAT THE DEATH WAS NOT ASSOCIATED WITH AN MI OR STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000744397

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death CLOPIDOGREL| ASPIRIN