BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER

    MDR report key: 8664700 · Received June 3, 2019

    Report

    Report Number
    2134265-2019-06142
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 21, 2019
    Report Date
    February 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

    DEVICE IS A COMBINATION PRODUCT. B3: DATE OF EVENT CORRECTED FROM (B)(6)2019 TO(B)(6)2019. B5: DESCRIBE EVENT OR PROBLEM - PATIENT DISCHARGE WAS CORRECTED TO LATE TO NINE DAYS LATER FROM THE PREVIOUSLY REPORTED SEVEN DAYS.

    Description of Event or Problem · 0

    PROMUS PREMIER CHINA CLINICAL STUDY IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6)2018 , THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 86% STENOSIS AND WAS 34MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.0X38MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. FIVE DAYS LATER, THE PATIENT WAS DISCHARGED ON ACETYLSALICYLIC ACID AND CLOPIDOGREL. IN (B)(6)2019 , THE PATIENT WAS NOTED WITH IN-STENT RESTENOSIS AND WAS HOSPITALIZED. THE 50% RESTENOSIS NOTED IN THE LMCA EXTENDING TO THE PROXIMAL LAD WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION. THE EVENT WAS CONSIDERED RECOVERED/RESOLVED ON THE SAME DAY AND THE PATIENT WAS DISCHARGED SEVEN DAYS LATER. IT WAS FURTHER REPORTED THAT, NINE DAYS LATER FROM HOSPITALIZATION, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND ON THE SAME DAY THE PATIENT WAS DISCHARGED.

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2018, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 86% STENOSIS AND WAS 34MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.0X38MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. FIVE DAYS LATER, THE PATIENT WAS DISCHARGED ON ACETYLSALICYLIC ACID AND CLOPIDOGREL. IN (B)(6) 2019, THE PATIENT WAS NOTED WITH IN-STENT RESTENOSIS AND WAS HOSPITALIZED. THE 50% RESTENOSIS NOTED IN THE LMCA EXTENDING TO THE PROXIMAL LAD WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION. THE EVENT WAS CONSIDERED RECOVERED/RESOLVED ON THE SAME DAY AND THE PATIENT WAS DISCHARGED SEVEN DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456486 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9554 0021425905

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention