BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 21978003 · Received May 7, 2025

    Report

    Report Number
    3015053838-2025-00065
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 14, 2025
    Report Date
    May 7, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. IT WAS REPORTED THAT THE PERFORATION OCCURRED POST-DEPLOYMENT OF THE DRUG-ELUTING STENT WHICH MAY HAVE CONTRIBUTED TO THE EVENT, HOWEVER, THE CAUSE OF THE PERFORATION COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. 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). 120 IVL PULSES WERE SUCCESSFULLY DELIVERED, FOLLOWING THE PLACEMENT OF A DRUG-ELUTING STENT (DES); A PERFORATION OCCURRED POST-DEPLOYMENT OF THE DES STENT. A COVERED STENT WAS PLACED TO TREAT THE PERFORATION, AND THE PATIENT WAS SUBSEQUENTLY TAKEN TO BYPASS SURGERY AT ANOTHER FACILITY. THE LATEST REPORT INDICATES THE PATIENT IS RECOVERING FROM CARDIAC SURGERY AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820704 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL3012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other COVERED STENT - UNKNOWN MANUFACTURER| DRUG ELUTING STENT (DES) - UNKNOWN MANUFACTURER| NONCOMPLIANT BALLOON - UNKNOWN MANUFACTURER