BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER

    MDR report key: 8818472 · Received July 23, 2019

    Report

    Report Number
    2134265-2019-08513
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    July 11, 2019
    Report Date
    February 19, 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. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED UNSTABLE ANGINA PECTORIS. IN JUNE 2019, THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA PECTORIS. THE TARGET LESION #1 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) TO DISTAL RCA WITH 100% STENOSIS AND WAS 46 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 MM X 28 MM AND 3.50 MM X 24 MM PROMUS PRIEMIERE STENTS. FOLLOWING THIS INTERVENTION, POST DILATATION WAS PERFORMED. POST PROCEDURAL STENOSIS WAS REPORTED AS 0%. EIGHT DAYS LATER, THE SUBJECT WAS DISCHARGED. IN (B)(6) 2019, 38 DAYS POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA PECTORIS AND WAS HOSPITALIZED ON THE SAME DAY. NO OTHER ACTION WAS TAKEN TO TREAT THE EVENT. THE OUTCOME OF THE EVENT WAS CONSIDERED TO BE RECOVERING/RESOLVING. IT WAS FURTHER REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AT A NON TARGET VESSEL REVASCULARIZATION TO TREAT THE EVENT AND, THEREFORE, IS NO LONGER RELATED TO THE STUDY DEVICES.

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED UNSTABLE ANGINA PECTORIS. IN (B)(6) 2019, THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA PECTORIS. THE TARGET LESION #1 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) TO DISTAL RCA WITH 100% STENOSIS AND WAS 46 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 MM X 28 MM AND 3.50 MM X 24 MM PROMUS PRIEMIERE STENTS. FOLLOWING THIS INTERVENTION, POST DILATATION WAS PERFORMED. POST PROCEDURAL STENOSIS WAS REPORTED AS 0%. EIGHT DAYS LATER, THE PATIENT WAS DISCHARGED. IN (B)(6) 2019, 38 DAYS POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA PECTORIS AND WAS HOSPITALIZED ON THE SAME DAY. NO OTHER ACTION WAS TAKEN TO TREAT THE EVENT. THE OUTCOME OF THE EVENT WAS CONSIDERED TO BE RECOVERING/RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610284 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9552 0022732382

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention