BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1163048 · Received September 15, 2008

    Report

    Report Number
    2024168-2008-00807
    Event Type
    Death
    Date Received
    September 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 18, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. ANGINA, MYOCARDIAL INFARCTION AND DEATH, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) ARE KNOWN RISKS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE STENT IMPLANT. IN THIS CASE, THE ANGINA WAS LIKELY A SYMPTOM OF THE MYOCARDIAL INFARCTION WHICH RESULTED IN DEATH. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: THE PT DIED; RELATIONSHIP TO DEVICE IS UNK. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRAIL THAT THE PT HAD A XIENCE V IMPLANTED APPROX FIVE MONTHS PRIOR TO THIS EVENT. REPORTEDLY, THE PT WAS CAMPING WITH HIS FAMILY AND DEVELOPED CHEST PAIN AT BED TIME. THE PT TOOK SOME ANTACID AND WENT TO SLEEP. UPON WAKING IN THE MORNING, THE WIFE FOUND THE PT DEAD. THE CAUSE OF DEATH WAS PRESUMED TO BE A Q-WAVE MYOCARDIAL INFARCTION BY THE LOCAL DOCTOR. IT IS UNK IF THE DEVICE IS RELATED TO THE DEATH. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death