BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER

    MDR report key: 17871176 · Received October 4, 2023

    Report

    Report Number
    3015053858-2023-00059
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    September 21, 2023
    Report Date
    May 19, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000089
    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 RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION. DURING THE INVESTIGATION, IT WAS FOUND THAT THE EMITTERS SHOWED SIGNS OF WEAR, INDICATING THAT THEY WERE FIRED AS EXPECTED. THE REPORTED BALLOON LOSS OF PRESSURE WAS CONFIRMED AS A PINHOLE WAS NOTED OVER EMITTER # 1. BASED ON THE REPORTED EVENT, THROMBOSIS WAS OBSERVED AT THE SITE WHERE THE COVERED STENT WAS IMPLANTED. THE THROMBOSIS WAS PERFUSED WITH MULTIPLE INFLATIONS USING BALLOON CATHETER AND PLACEMENT OF DRUG-ELUTING STENT (DES). THE CAUSE OF THE THROMBOSIS COULD NOT BE DEFINITIVELY DETERMINED. 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

    IT WAS REPORTED THAT DURING A PROCEDURE USING A SHOCKWAVE C2 CORONARY INTRAVASCULAR (IVL) CATHETER IN THE # 7 BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD), THE IVL BALLOON DELIVERED 10 PULSES. DURING THE 2ND CYCLE, THE BALLOON DELIVERED 7 PULSES. HOWEVER, THE BALLOON WAS FLUOROSCOPICALLY OBSERVED THAT THE PRESSURE WAS DECREASING, AND THE BALLOON WAS SIMULTANEOUSLY DIMINISHING IN SIZE. DURING IMAGING, A LEAKAGE FROM THE SAME TARGET VESSEL (LAD) WAS NOTED UNDER FLUOROSCOPY SO THE PHYSICIAN IMMEDIATELY PLACED A PAPYRUS COVERED STENT TO TAMPONADE THE LEAK. POST IVL TREATMENT, FULL AND PATENT HEMOSTASIS WAS ACHIEVED. THEN THE PHYSICIAN TREATED THE DISTAL TO PROXIMAL LESION IN THE #6 BRANCH OF THE LAD. DURING THE USE OF THE IVL CATHETER, IT WAS OBSERVED THAT THERE WAS A SLOW FLOW AND THROMBOSIS WAS NOTED AT THE SITE OF THE PAPYRUS STENT THAT WAS PLACED IN THE #7 BRANCH. IT WAS ALSO NOTED THAT THE PROXIMAL PART OF THE STENT WAS NOT A PRECISE CIRCLE. THE PHYSICIAN ASPIRATED THE THROMBUS AND PERFORMED LONG INFLATIONS USING A PERFUSION BALLOON CATHETER. THEN A BIOFREEDOM DRUG-COATED CORONARY STENT (DES) WAS IMPLANTED IN THE #6 BRANCH. THE INTENDED PROCEDURE WAS COMPLETED WITH NO ADDITIONAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122632 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. 2.5 X 12MM 09A230531A 00195451000089

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male BIOFREEDOM DES - BIOSENSORS| PAPYRUS COVERED STENT - BIOTRONIK| PERFUSION BALLOON CATHETER - UNKNOWN MFR