BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1765106 · Received July 19, 2010

    Report

    Report Number
    2024168-2010-01441
    Event Type
    Death
    Date Received
    July 19, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 24, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE PROMUS 3.0 X 23 MM (PART 1009529-23B, LOT 0012041) INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE #2 ISSUE: PHYSICAL RESISTANCE. ADVERSE EVENT: DISSECTION/MYOCARDIAL INFARCTION/DEATH. ONSET OF ADVERSE EVENT: DURING/POST PROCEDURE. IT WAS REPORTED THAT THE PT PRESENTED WITH CORONARY ARTERY DISEASE AND HAD A MYOCARDIAL INFARCTION (MI) LESS THAN 72 HOURS PRIOR TO THE PROCEDURE. THE PT ALSO EXPERIENCED A MYOCARDIAL INFARCTION AFTER THE STENT PLACEMENT. THE PHYSICIAN USED A PTCA BALLOON TO DO PRE-DILATION AND THEN IMPLANTED THE 2 PROMUS DRUG ELUTING STENTS (DES) TO COVER THE LESION IN THE DISTAL-RIGHT CORONARY ARTERY (RCA) TO MIDDLE-RCA. DURING THE PROCEDURE, THE PT WAS GIVEN NITROGLYCERIN AND HEPARIN. AFTER THE PROCEDURE WHICH TOOK PLACE IN THE MORNING, THE PT FELT MODERATE CHEST PAIN SO, HE WAS SENT TO THE ICU FOR OBSERVATION. THAT EVENING, THE PT SUFFERED FROM ACUTE CHEST PAIN. AFTER AN EVALUATION, A DISSECTION WAS NOTED IN THE RCA AND THE PT WAS SENT FOR SURGERY WHERE THE PT EXPIRED. THE DISSECTION WAS REPORTEDLY DUE TO THE VESSEL BEING HIGHLY CALCIFIED OR THE PT'S UNSTABLE CONDITION. IT WAS NOTED THAT A LITTLE RESISTANCE WAS FELT WHILE ADVANCING TO THE LESION DURING THE STENTING PROCEDURE. NO ADDITIONAL INFO WAS PROVIDED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 9110941

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R| S DIL CATH: SPRINTER (2.5X20MM, 3.0X20MM, 3.5X20MM)| GUIDE CATH: LAUNCHER 7F EBU| PROMUS 3.0 X 23 MM (PART 1009529-23B, LOT 0012041)| GUIDE WIRE: TERUMO FIELDER GW