BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 17769908 · Received September 18, 2023

    Report

    Report Number
    3015053858-2023-00057
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    September 4, 2023
    Report Date
    September 12, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. FOR INVESTIGATION THEREFORE, THE INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. BASED ON THE COMPLAINT DESCRIPTION, THE PATIENT EXPERIENCED DISSECTION DURING THE PROCEDURE. THE PHYSICIAN QUICKLY PLACED A STENT OVER THE DISSECTION AND ADMINISTERED ATROPINE INTRAVENOUSLY. AN IMPELLA HEART PUMP WAS ALSO INSERTED AS SUPPORT WHEN THE PATIENT BECAME BRADYCARDIC AND EXTREMELY HYPOTENSIVE. 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 A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A PATIENT WHO UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). ARTERIAL ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. AFTER THE IVL DELIVERED 40 PULSES, THE PATIENT EXPERIENCED A DISSECTION AND SUBSEQUENTLY BECAME BRADYCARDIC (30 BEATS) AND EXTREMELY HYPOTENSIVE (40 MM HG). A STENT WAS QUICKLY PLACED OVER THE DISSECTION AND ADMINISTERED ATROPINE INTRAVENOUSLY. AN IMPELLA HEART PUMP WAS ALSO INSERTED AS A SUPPORT. THEN THE PATIENT WAS PROVIDED CHEST COMPRESSIONS DUE TO LACK OF HEART RATE AND LACK OF HEMODYNAMICALLY STABLE PRESSURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ONE NIGHT AND WAS DISCHARGED THE FOLLOWING DAY. THE IMPELLA SUPPORT WAS REMOVED PRIOR TO DISCHARGE. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088132 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVLXXXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H| O IMPELLA HEART PUMP - UNKNOWN MANUFACTURER