BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER

    MDR report key: 21989355 · Received May 8, 2025

    Report

    Report Number
    2124215-2025-29291
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    April 13, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729828723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2019, A 4.00X38MM PROMUS PREMIER DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE PROXIMAL RAMUS CIRCUMFLEXUS (RCX). BY (B)(6) 2025, THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION IN LEFT ANTERIOR DESCENDING ARTERY (LAD), LEFT CIRCUMFLEX ARTERY (LCX), AND RCX. THE 70 TO 80% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE MILDLY TORTUOUS AND MODERATELY BUT NOT OPACIFIED PROXIMAL RCX. A 3.00X24MM SYNERGY DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE LAD FIRST, FOLLOWED WITH 2.25X24MM SYNERGY XD DES IN THE LCX. A 24X4.00MM PROMUS ELITE DES WAS ADVANCED IN THE RCX WITHOUT USING CONTRAST MEDIA BUT THE STENT GOT STUCK AT THE LEVEL OF ISR REGION AND FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, THE STENT WAS FOUND TO HAVE MULTIPLE STENT BURBS. A 3.50X20MM NON-BOSTON SCIENTIFIC BALLOON WAS USED TO PERFORM NUMEROUS INFLATIONS AT 24-26 ATMOSPHERES. FINALLY, A 4.00X28MM PROMUS ELITE DES WAS DEPLOYED COVERING THE ENTIRE LESION AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946260 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9554 08714729828723

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention