BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER

    MDR report key: 24568786 · Received March 11, 2026

    Report

    Report Number
    2124215-2026-13483
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    January 1, 2021
    Report Date
    April 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED. IN (B)(6) 2014, 90% IN-STENT RESTENOSIS (ISR) AT MID LEFT ANTERIOR DESCENDING (LAD) WAS SUCCESSFULLY IMPLANTED WITH A 2.50 MM X 20 MM PROMUS PREMIER DRUG ELUTING STENT. IN (B)(6) 2021, AN 80% ISR WAS NOTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) AND WAS SUCCESSFULLY TREATED WITH A 2.50 MM X 28 MM SYNERGY DRUG ELUTING STENT. IN (B)(6) 2021, ISR AT LAD WAS SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY. IN (B)(6) 2022, THE PATIENT PRESENTED WITH STABLE ANGINA. HEPARIN OR ANTITHROMBOTIC MEDICATIONS WERE ADMINISTERED. THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS) AND ANTIPLATELET MEDICATION OTHER THAN ASPIRIN (>= 72 HOURS). THE TARGET LESION WAS LOCATED AT THE MID LAD AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. ANGIOGRAPHY REVEALED 80% ISR AT THE MID LAD. AN IVUS CATHETER WAS ADVANCED, WHICH REVEALED NEOINTIMAL HYPERPLASIA WITH UNDER-EXPANSION. THE LESION WAS INITIALLY TREATED WITH LASER ATHERECTOMY. THE TARGET LESION WAS PREDILATED WITH A 3.00 MM X 15 MM BALLOON ANGIOPLASTY RESULTING INTO 10% RESIDUAL STENOSIS WITH TIMI FLOW 3. FOLLOWING PRE-DILATION, THE LESION WAS SUCCESSFULLY TREATED WITH A 3.00 MM X 20 MM AGENT DCB DEVICE WITH 10% RESIDUAL STENOSIS AND TIMI FLOW 3. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TRICAGRELOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629381 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H