BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 12081408 · Received June 28, 2021

    Report

    Report Number
    3015053858-2021-00011
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 16, 2021
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SHOCKWAVE AND THE EVALUATION WAS COMPLETED. BASED ON THE INVESTIGATION OBSERVATIONS, THE REPORTED BALLOON RUPTURE WAS CONFIRMED AND DETERMINED TO POSSIBLY BE ATTRIBUTED TO PATIENT CALCIUM WITHIN THE VESSEL THAT CAUSED DAMAGE TO THE BALLOON SURFACE, WHICH IS A KNOWN INHERENT RISK OF THE DEVICE. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SWMI'S ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Additional Manufacturer Narrative · 1

    THE DEVICE MENTIONED IN THE COMPLAINT WILL BE RETURNED FOR EVALUATION; EVALUATION IS ANTICIPATED BUT HAS NOT BEGUN. SHOCKWAVE MEDICAL (SWMI) 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 DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SWMI'S ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 1

    A SHOCKWAVE C2 (3.0 X 12MM) CORONARY LITHOTRIPSY (IVL) DEVICE WAS SUCCESSFULLY USED TO TREAT A PATIENT WITH SEVERELY CALCIFIED ARTERY, EXTENDING FROM THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) TO MID LAD. THE PROXIMAL LAD WAS PRE-DILATED, AND AN OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED TO CONFIRM VESSEL SIZING. 20 PULSES WERE DELIVERED TO PROXIMAL LAD, AND SUBSEQUENTLY C2 BALLOON WAS REPOSITIONED TO THE NEXT SEGMENT AROUND THE MID LAD. 20 PULSES WERE PLANNED FOR THIS SEGMENT; HOWEVER, A SUDDEN STAINING OF CONTRAST WAS OBSERVED AFTER 18 PULSES AT THE SAME SEGMENT. THE CATHETER WAS REMOVED FROM PATIENT IMMEDIATELY, AND BACKFLOW OF BLOOD INTO CATHETER AND INFLATION DEVICE WAS OBSERVED INDICATIVE OF A BALLOON LOSS OF PRESSURE. ANGIOGRAM FINDINGS SHOWED A SPIRAL DISSECTION HAD OCCURRED TOWARDS DISTAL AREA OF THE C2 BALLOON. PATIENT'S ECG CHANGES WERE DETECTED, AND AN ECHOCARDIOGRAM WAS PERFORMED TO VERIFY NEEDS OF CARDIAC TAMPONADE. THE DISSECTION WAS SUCCESSFULLY TREATED WITH THE PLACEMENT OF 2 DRUG ELUDING STENTS (DES) COVERING THE DISSECTION FROM THE PROXIMAL LAD TO MID LAD AND FURTHER DOWN. STENT OPTIMIZATION WAS CONFIRMED BY (B)(6). THE PATIENT WAS REPORTED TO HAVE HAD A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI), REQUIRING AN ECHOCARDIOGRAM, ADDITIONAL SCANS, AND LONGER OBSERVATION IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977319 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC C2IVL3012 A200521G

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other SAPPHIRE 3 (2.5MM X 15MM)