BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 12920605 · Received December 2, 2021

    Report

    Report Number
    3015053858-2021-00027
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 4, 2021
    Manufacturer
    SHOCKWAVE MEDICAL INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS NOT RETURNED BY THE REPORTING PARTY. THEREFORE, INSPECTION OF THE DEVICE COULD NOT BE PERFORMED, HOWEVER, THIS EVENT IS BEING ACKNOWLEDGED TO BE USED FOR TRENDING PURPOSES. THE ROOT CAUSE FOR THE MACE (MAJOR ADVERSE CARDIAC EVENT) AND PPMI (PERIPROCEDURAL MYOCARDIAL INFARCTION) COULD NOT BE DEFINITIVELY DETERMINED. BASED ON THE PHYSICIAN'S OPINION, THE PHYSICIAN REPORTED THAT THE SHOCKWAVE MEDICAL IVL PROCEDURE CAUSED THE PPMI. IT IS ALSO NOTED THAT PAIN AND MYOCARDIAL INFARCTION ARE DOCUMENTED ADVERSE EFFECTS IN THE DEVICE IFU. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTIONS. THE LOT CODE OF THE RETURNED DEVICE WAS NOT PROVIDED. THEREFORE, REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED. HOWEVER, SWMI HAS TESTS AND PROCEDURES IN PLACE TO ENSURE DEVICE LOT ACCEPTANCE PRIOR TO RELEASING FOR DISTRIBUTION.

    Description of Event or Problem · 0

    A 3.5MM IVL CATHETER WAS USED TO TREAT A LONG 32MM MLAD LESION. DURING ENERGY DELIVERY, THE PATIENT EXPERIENCED SEVERE CHEST PAIN WITH NO EVIDENCE OF MAJOR DISSECTION; ALL 80 PULSES WERE DELIVERED AND THE PATIENT WAS STENTED AFTER THE SUCCESSFUL IVL PROCEDURE. THERE WERE NO DEVICE MALFUNCTIONS NOTED. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT AND THE CHEST PAIN WAS RESOLVED 12 HOURS POST PROCEDURE AND THE PATIENT DISCHARGED. THE PHYSICIAN INDICATED THAT THE CHEST PAIN WAS DUE TO IVL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818618 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL INC. C2IVL3512

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Hospitalization| L NC BALLOON-UNKNOWN MFG. (NOT A SWMI PRODUCT).