BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1689752 · Received May 12, 2010

    Report

    Report Number
    2953200-2010-00832
    Event Type
    Death
    Date Received
    May 12, 2010
    Date of Event
    December 4, 2009
    Report Date
    April 14, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION RESULTS: DEATH.

    Description of Event or Problem · 1

    PATIENT HAS A HISTORY OF NON-IDDM. PATIENT'S CARDIAC STATUS AT TIME OF INDEX PROCEDURE WAS ACUTE MI (BIOMARKERS POSITIVE). THE PATIENT HAD ONE LESION TREATED. ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO PROX LAD. PATIENT WAS ASYMPTOMATIC AT 1 MONTH, 6 MONTH, 1 YEAR, 1.5 YEAR AND 2 YEAR FOLLOW-UP. APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE, INVESTIGATOR REPORTS PATIENT DEATH. INVESTIGATOR CLASSIFIED DEATH AS A SUDDEN DEATH. INVESTIGATOR PROVIDED THE FOLLOWING NARRATIVE "TELEPHONIC FOLLOW UP WITH PATIENT'S SON, INFORMED ABOUT SUDDEN DEATH OF PATIENT. SUDDEN ONSET OF BREATHLESSNESS FOLLOWED BY COLLAPSE WITHIN 20 MIN BEFORE REACHING HOSPITAL. NO EVENT RELATED DOCUMENTS." INVESTIGATOR DID NOT ASSESS THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death CLOPIDOGREL| PATIENT WAS TAKING ASA| 24 HOURS PRIOR TO EVENT.| TICLOPIDINE