BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS PREMIER

    MDR report key: 10684444 · Received October 15, 2020

    Report

    Report Number
    2134265-2020-13802
    Event Type
    Death
    Date Received
    October 15, 2020
    Date of Event
    July 20, 2020
    Report Date
    November 4, 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

    (B)(6). CORRECTIONS: B2 OUTCOMES ATTRIB TO ADV EVENT/DATE OF DEATH INITIALLY REPORTED AS DEATH AND (B)(6) 2020 AND CORRECTED TO BLANK AS DEATH DID NOT OCCUR.

    Description of Event or Problem · 0

    PROMUS PREMIER CHINA REGISTRY. IT WAS REPORTED THAT THE SUBJECT DIED. IN (B)(6) 2018, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) EXTENDING TO DISTAL RCA WITH 100% STENOSIS AND WAS 30 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.50 X 32 MM PROMUS PREMIER STENT. FOLLOWING THIS, POST-DILATATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. FIVE DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN. IN (B)(6) 2020, 704 DAYS POST INDEX PROCEDURE, THE SUBJECT DIED. IT WAS FURTHER REPORTED THAT THE SUBJECT DID NOT DIE. THE SUBJECT HAD NO SYMPTOMS AND THE CLINICAL FORM WAS COMPLETED INADVERTENTLY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT DIED. IN AUGUST 2018, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) EXTENDING TO DISTAL RCA WITH 100% STENOSIS AND WAS 30 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.50 X 32 MM PROMUS PREMIER STENT. FOLLOWING THIS, POST-DILATATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. FIVE DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN. IN JULY 2020, 704 DAYS POST INDEX PROCEDURE, THE SUBJECT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149081 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9553 0021779301

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death