BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS PREMIER

    MDR report key: 9163218 · Received October 7, 2019

    Report

    Report Number
    2134265-2019-12113
    Event Type
    Death
    Date Received
    October 7, 2019
    Date of Event
    August 17, 2019
    Report Date
    May 26, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS DEVICE WAS REPORTED IN ERROR.

    Description of Event or Problem · 0

    PROMUS PREMIER CHINA REGISTRY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION, HEART FAILURE OCCURRED AND PATIENT DIED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED THE TARGET LESION #1 LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 10MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 MM X 12 MM AND 2.75MM X 16 MM PROMUS PREMIER STENTS. FOLLOWING POST DILATION THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS LOCATED IN THE MID LAD WITH 90% STENOSIS, AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 16 MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. TEN DAYS AFTER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2019, 93 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION WHICH LED TO THE PROLONGATION OF EXISTING HOSPITALIZATION. IT WAS NOTED THE EVENT LED TO THE SERIOUSNESS CRITERIA OF LIFE THREATENING ILLNESS/INJURY BUT WAS NOT MEDICALLY TREATED. FIVE DAYS LATER, THE SUBJECT PASSED AWAY. DEATH CERTIFICATE AND AUTOPSY REPORTS ARE NOT AVAILABLE FOR THE EVENT AT THE MOMENT. IT WAS PREVIOUSLY REPORTED THAT TWO STENTS WERE IMPLANTED IN THE LMCA TO MID-LAD, BUT NOW IT IS REPORTED THE TARGET LESION #1 WAS ONLY LOCATED IN THE LMCA AND WAS 10MM LONG. THE LESION WAS TREATED WITH ONLY ONE STENT, THE 3.50X12MM PROMUS PREMIER STENT.

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION, HEART FAILURE OCCURRED AND PATIENT DIED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED THE TARGET LESION #1 LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 10MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 MM X 12 MM AND 2.75MM X 16 MM PROMUS PREMIER STENT. FOLLOWING POST DILATION THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS LOCATED IN THE MID LAD WITH 90% STENOSIS, AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 16 MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. TEN DAYS AFTER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2019, 93 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION WHICH LED TO THE PROLONGATION OF EXISTING HOSPITALIZATION. IT WAS NOTED THE EVENT LED TO THE SERIOUSNESS CRITERIA OF LIFE THREATENING ILLNESS/INJURY BUT WAS NOT MEDICALLY TREATED. FIVE DAYS LATER, THE SUBJECT PASSED AWAY. DEATH CERTIFICATE AND AUTOPSY REPORTS ARE NOT AVAILABLE FOR THE EVENT AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958254 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9549 0022911076

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death