BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER

    MDR report key: 8860898 · Received August 5, 2019

    Report

    Report Number
    2134265-2019-09206
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    June 3, 2019
    Report Date
    September 2, 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.

    Description of Event or Problem · 0

    PROMUS PREMIER CHINA REGISTRY CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED CORONARY SYNDROME. IN (B)(6) 2019, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION #1 WAS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY EXTENDING INTO THE DISTAL CX WITH 90% STENOSIS AND WAS 62 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 MM X 32 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. THREE DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND OTHER ANTIPLATELET MEDICATION. IN (B)(6) 2019, 45 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED CORONARY SYNDROME AND WAS HOSPITALIZED FOR FURTHER EVALUATION ON THE SAME DAY. THE EVENT WAS NOT TREATED MEDICALLY AND THE OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE BUT HAS BEEN REQUESTED. IT WAS FURTHER REPORTED THAT IN (B)(6) 2019, THE SUBJECT EXPERIENCED ACUTE CORONARY SYNDROME AND WAS DISCHARGED ON THE SAME DAY OF HOSPITALIZATION.

    Description of Event or Problem · 0

    PROMUS PREMIER CHINA REGISTRY CLINICAL STUDY IT WAS REPORTED THAT PATIENT EXPERIENCED CORONARY SYNDROME. IN (B)(6) 2019, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION #1 WAS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY EXTENDING INTO THE DISTAL CX WITH 90% STENOSIS AND WAS 62 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 MM X 32 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. THREE DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND OTHER ANTIPLATELET MEDICATION. IN (B)(6) 2019, 45 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED CORONARY SYNDROME AND WAS HOSPITALIZED FOR FURTHER EVALUATION ON THE SAME DAY. THE EVENT WAS NOT TREATED MEDICALLY AND THE OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE BUT HAS BEEN REQUESTED. IT WAS FURTHER REPORTED THAT IN (B)(6) 2019, THE SUBJECT EXPERIENCED ACUTE CORONARY SYNDROME AND WAS DISCHARGED ON THE SAME DAY OF HOSPITALIZATION. IT WAS LATER REPORTED THAT THE EVENT WAS TREATED MEDICALLY AND CONSIDERED TO BE RECOVERED.

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED CORONARY SYNDROME. IN (B)(6) 2019, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION #1 WAS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY EXTENDING INTO THE DISTAL CX WITH 90% STENOSIS AND WAS 62 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 MM X 32 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. THREE DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND OTHER ANTIPLATELET MEDICATION. IN (B)(6) 2019, 45 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED CORONARY SYNDROME AND WAS HOSPITALIZED FOR FURTHER EVALUATION ON THE SAME DAY. THE EVENT WAS NOT TREATED MEDICALLY AND THE OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE BUT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654568 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9553 0022401676

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention