BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 20472813 · Received October 17, 2024

    Report

    Report Number
    3015053858-2024-00121
    Event Type
    Death
    Date Received
    October 17, 2024
    Date of Event
    September 24, 2024
    Report Date
    October 17, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000003
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS DISCARDED AND WILL NOT BE RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. BASED ON THE REPORTED INFORMATION, A DISSECTION WAS OBSERVED VIA ANGIOGRAPHY AND THE PATIENT EXPERIENCED RAPID HEMODYNAMIC DECLINE AND SUBSEQUENTLY EXPIRED. THERE WAS NO C2+ IVL MALFUNCTION REPORTED, AND THE SITE INDICATED THAT THEY DO NOT BELIEVE THE DISSECTION WAS A RESULT OF THE C2+ DEVICE. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 0

    A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT RADIAL ACCESS WAS OBTAINED USING A 6FR SHEATH, THEN A GUIDEWIRE WAS PLACED IN THE LAD. A SAPPHIRE BALLOON WAS INFLATED TWICE AT 8 ATM IN THE MID-LAD, WITH A SUBSEQUENT INFLATION; HOWEVER, THE ATM IS UNKNOWN. THE C2+ WAS THEN POSITIONED IN THE LAD AND INFLATED TO 4 ATM AND 100 PULSES WERE DELIVERED. THIS WAS FOLLOWED BY THE PLACEMENT OF AN NC NEO TREK BALLOON, BUT THE ATM FOR THIS INFLATION IS UNKNOWN. FOLLOWING ANGIOGRAPHY, A DISSECTION WAS OBSERVED BOTH PROXIMALLY AND DISTALLY IN THE LAD; THE DISSECTION GRADE WAS NOT REPORTED. THE PATIENT EXPERIENCED RAPID HEMODYNAMIC DETERIORATION AND CODED ON THE TABLE. THE STAFF INDICATED THAT THEY DO NOT BELIEVE THE DISSECTION WAS A RESULT OF THE C2+ DEVICE. NO STENT WAS PLACED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035025 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL2512 01A240220A 00195451000003

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death NC NEO TRACK - BALLOON| PHILLIPS - IVUS CATHETER| SAPPHIRE - BALLOON