BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER

    MDR report key: 22331316 · Received June 25, 2025

    Report

    Report Number
    2124215-2025-42103
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729828662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT OR PROBLEM UPDATED. E1. INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL MID-RIGHT CORONARY ARTERY (RCA). A 3.50 X 32 MM PROMUS PREMIER WAS DEPLOYED AND A TYPE B FLOW-LIMITING DISSECTION OCCURRED AT THE DISTAL STENT EDGE. PER THE OPERATING PHYSICIAN, LIPID RICH PLAQUE CONTRIBUTED TO THE OCCURRENCE ODF THE DISSECTION AND TIMI II FLOW. A 3.00 X 16 MM PROMUS PREMIER WAS DEPLOYED TO COVER THE DISTAL STENT EDGE DISSECTION. THE PROCEDURE WAS COMPLETED, AND THE PATIENT FULLY RECOVERED AND REMAINED STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL MID-RIGHT CORONARY ARTERY (RCA). A 3.50 X 32 MM PROMUS PREMIER WAS DEPLOYED, AND A TYPE B FLOW-LIMITING DISSECTION OCCURRED AT THE DISTAL STENT EDGE. PER THE OPERATING PHYSICIAN, LIPID RICH PLAQUE CONTRIBUTED TO THE OCCURRENCE OF THE DISSECTION AND TIMI II FLOW. A 3.00 X 16 MM PROMUS PREMIER WAS DEPLOYED TO COVER THE DISTAL STENT EDGE DISSECTION. THE PROCEDURE WAS COMPLETED, AND THE PATIENT FULLY RECOVERED AND REMAINED STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED. PRE-DILATATION WAS THEN PERFORMED WITH A 2.50 X 12 MM NON-COMPLIANT BALLOON. THE STENT WAS FULLY INFLATED WITHOUT ISSUES AT 16 ATMOSPHERES (ATM) FOR 10 SECONDS, AND A 3.50 X 12 MM NON-COMPLIANT BALLOON WAS USED TO POST-DILATE THE STENT AT 16 ATM FOR 15 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398457 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9553 0033938229 08714729828662

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention