BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER

    MDR report key: 15632396 · Received October 19, 2022

    Report

    Report Number
    3015053858-2022-00062
    Event Type
    Death
    Date Received
    October 19, 2022
    Date of Event
    September 29, 2022
    Report Date
    September 29, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000096
    PMA / PMN Number
    P200039
    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 COULD NOT BE PERFORMED. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. BASED ON THE PROVIDED INFORMATION, THE PATIENT EXPERIENCED LEFT CIRCUMFLEX (LCX) AND LEFT MAIN (LM) ARTERY PERFORATIONS. COVERED STENTS WERE IMMEDIATELY DEPLOYED HOWEVER, UNDER IMAGING, THERE WAS STILL PRESENCE OF BLEEDING. THE PATIENT WAS EMERGENTLY TRANSFERRED TO THE OPERATING ROOM FOR SURGERY TO STOP THE BLEEDING. HOWEVER, THE PATIENT CODED AND SUBSEQUENTLY EXPIRED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A PATIENT HAD A VENTRICULAR HEART PUMP PROCEDURE DUE TO CORONARY ARTERY DISEASE (CAD), THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) USING THE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR CORONARY (LAD) AND CIRCUMFLEX (CX) ARTERIES. THE BALLOON SUCCESSFULLY DELIVERED 40 PULSES IN EACH VESSEL. POST IVL PROCEDURE, A DRUG-ELUTING STENTS (DES) WERE DEPLOYED IN THE LEFT CIRCUMFLEX AND PROXIMAL LAD. THE LAD AND THE CX WERE POST-DILATED WITH NON-COMPLIANT (NC) BALLOONS. FOLLOWING POST-DILATATION AND CONTRAST INJECTION, THE PATIENT'S BLOOD PRESSURE WAS OBSERVED TO BE DROPPING. AFTER FURTHER IMAGING, IT WAS DISCOVERED THAT THE LEFT CX AND THE LEFT MAIN (LM) WERE PERFORATED. COVERED STENTS WERE IMMEDIATELY DEPLOYED TO TREATMENT THE PERFORATIONS. ANGIOGRAPHY SHOWED THE BLEEDING HAD SUBSIDED HOWEVER, DUE TO THE STABILITY OF THE PATIENT, AND THE ECHOGRAM STILL SHOWING BLEEDING, THE PATIENT WAS EMERGENTLY TRANSPORTED TO THE OPERATING ROOM (OR) FOR SURGERY TO STOP THE BLEEDING. AFTER THE SURGERY, THE PATIENT WAS TRANSFERRED BACK TO THE ICU ON IMPELLA SUPPORT AND WAS RETURNED TO SURGERY THE FOLLOWING MORNING IN AN ATTEMPT TO FIND AND STOP THE BLEEDING, WHICH WAS UNSUCCESSFUL, AND THE PATIENT CODED AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222973 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER INTRAVASCULAR LITHOTRIPSY (IV) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 A220324B   00195451000096

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Death IMPELLA VENTRICULAR SUPPORT SYSTEM - ABIOMED.| NON-COMPLIANT BALLOON CATHETERS - UNK MANUFACTURER.| PK PAPYRUS CONVERED STENTS - BIOTRONIK.| RESOLUTE ONYX DRUG-ELUTING STENT (DES) - MEDTRONIC.