BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 21454385 · Received February 24, 2025

    Report

    Report Number
    3015053838-2025-00032
    Event Type
    Injury
    Date Received
    February 24, 2025
    Report Date
    February 24, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE THROMBUS COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. IT WAS REPORTED THAT THE THROMBUS OCCURRED POST DES IMPLANTATION. THERE WAS NO IVL MALFUNCTION REPORTED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THEREFORE, REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED. HOWEVER, SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE WAS NO IVL MALFUNCTION REPORTED. A DRUG ELUTING STENT (DES) WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES. AFTER THE PROCEDURE, THE PATIENT WAS COLD SWEATING AND ST ELEVATION WAS OBSERVED. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS CONDUCTED AGAIN. THROMBUS WAS OBSERVED IN THE DES THAT WAS JUST IMPLANTED SO THROMBUS ASPIRATION WAS PERFORMED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269051 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVLXXXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other DRUG ELUTING STENT - UNKNOWN MANUFACTURER