BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 20233651 · Received September 16, 2024

    Report

    Report Number
    3015053858-2024-00104
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    January 4, 2024
    Report Date
    September 16, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000096
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CANNOT BE PERFORMED. THE CAUSE OF THE MYOCARDIAL INFARCTION COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL MALFUNCTION REPORTED. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. 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.

    Description of Event or Problem · 0

    A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. MYOCARDIAL INFARCTION OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A ROTABLATOR AND IVL FOLLOWED BY DRUG-ELUTING STENT (DES) PLACEMENT. DURING THE USE OF THE ROTABLATOR, SLOW-FLOW TEMPORARILY OCCURRED BECAUSE OF SLIGHT DISTAL EMBOLIZATION, WHICH RECOVERED AFTER INTRACORONARY INJECTION OF NICORANDIL. SLIGHT ELEVATED CARDIAC ENZYMES WERE OBSERVED AND BECAME PERIOPERATIVE NON-Q-WAVE MYOCARDIAL INFARCTION (NON-QMI) BUT THE PATIENT RECOVERED WITH NO ISSUE. THE PHYSICIAN COMMENTED THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND IVL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AS PLANNED WITH NO EXTENSION OF HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531292 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 06A230804A 00195451000096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other DRUG-ELUTING STENT (DES) - UNKNOWN MANUFACTURER| ROTABLATOR - UNKNOWN MANUFACTURER