BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 18192985 · Received November 22, 2023

    Report

    Report Number
    3015053858-2023-00067
    Event Type
    Death
    Date Received
    November 22, 2023
    Date of Event
    November 15, 2023
    Report Date
    May 23, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    001954100010
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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, NO INVESTIGATION CAN BE PERFORMED. BASED ON THE REPORTED EVENT, THE PATIENT EXPERIENCED CHEST PAIN AND DECREASED BLOOD PRESSURE DURING THE LAST ROUND OF IVL TREATMENT. THE PHYSICIAN IMMEDIATELY IMPLANTED A DRUG-ELUTING STENT AND INSERTED AN IMPELLA HEART PUMP. HOWEVER, THE PATIENT CODED AND SUBSEQUENTLY EXPIRED WHILE STILL ON THE CATH LAB TABLE. 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. SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED.

    Additional Manufacturer Narrative · 0

    SEE CORRECTION TO D4: UDI.

    Description of Event or Problem · 0

    A 79-YEAR-OLD MALE PATIENT UNDERWENT A PLANNED IN-PATIENT PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE DUE TO A CHRONIC TOTAL OCCLUSION (CTO). THE PROCEDURE WAS TO TREAT A BLOCKAGE/DISEASE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY TO THE LEFT MAIN (LM). ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. IT WAS REPORTED THAT THE PATIENT WAS PROVIDED A TOTAL OF FOUR ROUNDS OF TREATMENT USING A C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. DURING THE PROCEDURE, THE PATIENT'S EJECTION FRACTION (EF) WAS BETWEEN 35-40 AND STARTED TO HAVE CHEST PAIN DURING THE LAST ROUND OF IVL TREATMENT. THE PATIENT'S BLOOD PRESSURE ALSO STARTED TO DECREASE SO THE PHYSICIAN IMMEDIATELY IMPLANTED A SYNERGY DRUG-ELUTING STENT. THE PHYSICIAN ALSO INSERTED AN IMPELLA DEVICE, HOWEVER, THE PATIENT STARTED TO CODE. THE PATIENT SUBSEQUENTLY EXPIRED WHILE STILL ON THE CATH LAB TABLE. THE WAS NO IVL DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757817 SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL3012 06A230511A 001954100010

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Death IMPELLA HEART PUMP| SYNERGY DRUG-ELUTING STENT