BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 16844958 · Received May 1, 2023

    Report

    Report Number
    3015053858-2023-00024
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 5, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000089
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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, A PHYSICAL INVESTIGATION OF THE DEVICE CANNOT BE PERFORMED. BASED ON THE REPORTED EVENT, TWO IVL CATHETERS WERE USED FOR THIS PROCEDURE. BOTH CATHETERS DISPLAYED ERROR 88 AFTER DELIVERING PULSES. HOWEVER, BIOMED TESTED THE 2ND IVL AND IT PERFORMED AS DESIGNED AND NO ERROR OCCURRED. THE REPORTED ABRUPT VESSEL CLOSURE OCCURRED FOUR DAYS AFTER THE IVL TREATMENT, AND THE PATIENT EXPERIENCED A SECOND ABRUPT VESSEL CLOSURE THREE DAYS LATER. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR THE 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. 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. REFERENCE:2ND IVL DEVICE (B)(6), MODEL/CATALOG # C2IVL2512, LOT # B210714C, EXPIRATION DATE: 07/31/2023, MANUFACTURING DATE: 7/14/2021, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN IN-PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. DURING THE INITIAL USE OF THE SHOCKWAVE C2 INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER, THE BALLOON DELIVERED 10 PULSES AND THEN THE GENERATOR DISPLAYED ERROR 88. A SECOND IVL WAS PREPPED AND USED, DELIVERED 18 PULSES. HOWEVER, THE SAME ERROR OCCURRED. FOUR DAYS FOLLOWING THE IVL TREATMENT, THE PATIENT EXPERIENCED ACUTE SEVERE CHEST PAIN WHICH SUBSEQUENTLY CAUSED THE TREATED LEFT MAIN TO CLOSE ABRUPTLY. THE PHYSICIAN PERFORMED A SECOND PCI TO OPEN THE LEFT MAIN. IT WAS REPORTED THAT THE CALCIUM WASN'T FULLY EXPANDED BECAUSE OF INCOMPLETE EXPANSION AND DUE TO INADEQUATE CALCIUM MODIFICATION. THE PHYSICIAN SUCCESSFULLY TREATED THE CLOSED VESSEL WITH STENT IMPLANTATION AND POST DILATATION OF THE VESSEL USING A NON-COMPLIANT (NC) BALLOON. THREE DAYS LATER, THE PATIENT SUFFERED A SECOND ABRUPT VESSEL CLOSURE. TO DATE, THERE HAVE BEEN NO UPDATES ON THE STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275189 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 C220822B 00195451000089

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| O| R