BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER

    MDR report key: 18954534 · Received March 21, 2024

    Report

    Report Number
    2124215-2024-17273
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    March 9, 2024
    Report Date
    May 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHED TO THE COMPLAINT RECORD WAS CINE MEDIA. MEDIA REVIEW BY A BSC MEDICAL SAFETY DIRECTOR OBSERVED AN EDGE DISSECTION DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH SUCCESSFUL TREATMENT WITH ANOTHER STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL-MID RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE DILATION OF LESION WITH A 2.50 X 12 MM NON-COMPLIANT BALLOON, A 3.00 X 38 MM PROMUS PREMIER STENT WAS DEPLOYED AT 16 ATM FOR 10 SEC. A 3.00 X 12 MM NON-COMPLIANT BALLOON WAS USED TO POST DILATE THE STENT AND A DISTAL EDGE TYPE B DISSECTION WAS NOTED. THE PATIENT EXPERIENCED SLOW FLOW. THE DISSECTION WAS COVERED WITH ANOTHER 2.75 X 12 MM PROMUS PREMIER STENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT FULLY RECOVERED AND WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL-MID RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE DILATION OF LESION WITH A 2.50 X 12 MM NON-COMPLIANT BALLOON, A 3.00 X 38 MM PROMUS PREMIER STENT WAS DEPLOYED AT 16 ATM FOR 10 SEC. A 3.00 X 12 MM NON-COMPLIANT BALLOON WAS USED TO POST DILATE THE STENT AND A DISTAL EDGE TYPE B DISSECTION WAS NOTED. THE PATIENT EXPERIENCED SLOW FLOW. THE DISSECTION WAS COVERED WITH ANOTHER 2.75 X 12 MM PROMUS PREMIER STENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT FULLY RECOVERED AND WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555154 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9554 0032553013

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention