BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 18924408 · Received March 18, 2024

    Report

    Report Number
    3015053858-2024-00023
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    July 12, 2023
    Report Date
    March 18, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000089
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION THEREFORE, A PHYSICAL INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. THE CAUSE OF THE THROMBUS THAT OCCURRED POST IVL TREATMENT COULD NOT BE DEFINITIVELY DETERMINED. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. FOLLOWING CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATION OF THIS EVENT, IT WAS NOTED THAT THE THROMBUS IN THE LESION WAS DUE TO RETROGRADE EXTENSION OF HEMATOMA FROM THE CFX (TARGET LESION) PROBABLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE . A REVIEW OF THE LOT HISTORY RECORD (LHR) AND TEST DOCUMENTATION DID NOT SHOW ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL SHOCKWAVE MEDICAL, INC. CRITERIA PRIOR TO BEING RELEASED FOR DISTRIBUTION. 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

    A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A LESION LOCATED IN THE LEFT CIRCUMFLEX (CFX). PERI-PROCEDURE, THE PATIENT WAS PROVIDED 7000 UNITS OF HEPARIN. THE IVL BALLOON SUCCESSFULLY DELIVERED 30 PULSES WITH NO MALFUNCTION OF THE DEVICE REPORTED. TWENTY-THREE MINUTES (23) AFTER THE COMPLETION OF THE INDEX PROCEDURE, THE PATIENT REPORTED CHEST PAIN. THE PATIENT WAS SENT BACK FOR IMAGING AND A CORONARY THROMBUS WAS NOTED IN THE NON-TARGET LESION. THE PATIENT UNDERWENT A SECOND PCI (REVASCULARIZATION) ON THE SAME DAY. DURING A SECOND PCI REVASCULARIZATION PROCEDURE, THERE WAS BLEEDING IN THE LEFT GROIN AND PATIENT'S SYSTOLIC BLOOD PRESSURE (SBP) WAS AT 80MMHG. THE PATIENT WAS PROVIDED ATROPINE DELIVERED INTRAVENOUSLY (IV), GIVEN REGLAN FOR NAUSEA, NOREPINEPHRINE INFUSION, AND ONE UNIT OF PACKED RED BLOOD CELLS (PRBC). THEN AN ULTRASOUND WAS PERFORMED, AND THE PATIENT WAS NEGATIVE FOR PSEUDOANEURYSM. AFTER MONITORING, THE PATIENT WAS SUBSEQUENTLY DISCHARGED TO HOME. FOLLOWING CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATION OF THIS EVENT, IT WAS NOTED THAT THE THROMBUS IN THE LESION WAS DUE TO RETROGRADE EXTENSION OF HEMATOMA FROM THE CFX (TARGET LESION) PROBABLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342658 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 A221109C 00195451000089

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| O NC TREK CORONARY DILATATION CATHETER - ABBOT CARDI| XIENCE SKYPOINT¿ DRUG-ELUTING STENT (DES) ABBOTT