BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER

    MDR report key: 11773651 · Received May 4, 2021

    Report

    Report Number
    2134265-2021-05387
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    March 4, 2021
    Report Date
    June 3, 2021
    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

    UPDATED B5: DESCRIBE EVENT OR PROBLEM (A1) PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 0

    PROMUS PREMIER CHINA REGISTRY. IT WAS REPORTED THAT UNSTABLE ANGINA OCCURRED. IN MARCH 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA (BRAUN WALD CLASSIFICATION-UNKNOWN), WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) EXTENDING UP TO POSTERIOR DESCENDING ARTERY (PDA) WITH 80% STENOSIS AND WAS 16MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.25MM X 20MM PROMUS PREMIER STENT. FOLLOWING THIS, POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. TWO DAYS LATER, SUBJECT DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6)2021, 717 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION AND TREATMENT. THE EVENT WAS TREATED MEDICALLY AND TWO DAYS LATER, WAS CONSIDERED RECOVERED/RESOLVED. ON THE SAME DAY THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IT WAS FURTHER REPORTED THAT MEDICATION WAS ADJUSTED AND CORONARY ANGIOGRAPHY ALONG WITH BALLOON DILATATION WAS PERFORMED TO TREAT THE EVENT. FURTHERMORE, THE EVENT WOULD QUALIFY FOR TARGET VESSEL REVASCULARIZATION WITH THE JUSTIFICATION STATING, 'RIGHT CROWN AND LEFT VENTRICULAR POSTERIOR BRANCH'. THE CORONARY ANGIOGRAPHY REVEALED 80% STENOSIS IN THE TARGET LESION, R-PDA WHICH HAD PREVIOUSLY PLACED STUDY DEVICE, WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI). POST INTERVENTION, RESIDUAL STENOSIS WAS 0% AND THE INTERVENTIONAL RATIONAL WAS ANGINA.

    Description of Event or Problem · 1

    (B)(6) REGISTRY. IT WAS REPORTED THAT UNSTABLE ANGINA OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA (BRAUN WALD CLASSIFICATION-UNKNOWN), WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) EXTENDING UP TO POSTERIOR DESCENDING ARTERY (PDA) WITH 80% STENOSIS AND WAS 16MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.25MM X 20MM PROMUS PREMIER STENT. FOLLOWING THIS, POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. TWO DAYS LATER, SUBJECT DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2021, 717 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION AND TREATMENT. THE EVENT WAS TREATED MEDICALLY AND TWO DAYS LATER, WAS CONSIDERED RECOVERED/RESOLVED. ON THE SAME DAY THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668170 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9550 0022893300

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R