BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 20348850 · Received October 1, 2024

    Report

    Report Number
    3015053858-2024-00112
    Event Type
    Death
    Date Received
    October 1, 2024
    Report Date
    October 1, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    PMA / PMN Number
    K203365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 DISSECTION, PERFORATION, AND SUBSEQUENT DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL DEVICE 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 M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED IN A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) CASE. IT WAS REPORTED THAT ACCESS WAS DIFFICULT AND THE IVL CATHETER WAS USED TO FACILITATE ACCESS AND DELIVERY OF THE TAVI SHEATH. THE TAVI SHEATH WAS PUT IN PLACE AFTER THE USE OF IVL THERAPY. A MAJOR DISSECTION OF UNKNOWN GRADE AND RUPTURE OF THE ILIAC AND AORTA OCCURRED IN WHICH THE PATIENT DID NOT SURVIVE. IT IS UNKNOWN EXACTLY WHEN THE DISSECTION AND DEATH OCCURRED. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. THERE IS NO AVAILABLE INFORMATION ON THE PATIENT, EVENT DATE, OR THE DEVICE RELATEDNESS. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40384 SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. M5PIVL7060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SHEATH - UNKNOWN MANUFACTURER