BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 12018591 · Received June 17, 2021

    Report

    Report Number
    3015053858-2021-00009
    Event Type
    Injury
    Date Received
    June 17, 2021
    Report Date
    May 19, 2021
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION REPORTED, THE MANUFACTURER BELIEVES THAT THE STATEMENT, 'EMBOLIZATION OF BALLOON CONTENTS' IS REFERRING TO THE 50/50 SALINE/ CONTRAST WITHIN THE BALLOON DURING INFLATION THAT WAS EMBOLIZED INTO THE BLOODSTREAM UPON RUPTURE OF THE BALLOON. HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED WITH THE LIMITED INFORMATION AVAILABLE RELATED TO THIS EVENT. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. THE DEVICE MENTIONED IN THE COMPLAINT WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. HENCE A PHYSICAL INSPECTION OF THE DEVICE WAS NOT POSSIBLE. 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 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

    EVENT REPORTED VIA JOURNAL ARTICLE: KAUR ET AL.; AJCR, 4(1): 8-13, 2021; ARTICLE NO.AJCR.65254. THE RIGHT CORONARY ARTERY (RCA) WAS TREATED FIRST, AS THIS STRATEGY WOULD PROVIDE THE REQUIRED SUPPORT OF RIGHT CORONARY CIRCULATION TO TOLERATE INTERVENTION ON LEFT SYSTEM. THE TORTUOUS RCA WAS ENGAGED WITH 7 FRENCH (F) JUDKIN RIGHT 3.5 GUIDING CATHETER AND WAS WIRED WITH 0.0014" ASAHI SION BLUE. AFTER DEEP INTUBATION WITH 6F GUIDE EXTENSION, THE DIFFUSE CALCIFIED LESION WAS SEQUENTIALLY PREDILATED WITH 1.2 X 8 MM, 2 X 12 MM AND 2.5 X 8 MM SC BALLOONS AND THE PLAQUE WAS FURTHER MODIFIED USING 2.5 X 10 MM CUTTING BALLOON (FLEXITOMETM, BOSTON SCIENTIFIC). SINCE WE COULD NOT DELIVER 2.5 X 12 MM SHOCKWAVE C2 IVL BALLOON TO THE CALCIFIED AREA, THE LESION WAS FURTHER DILATED USING 2.75 X 12 AND 3 X 8 MM NON-COMPLIANT (NC) BALLOONS; FOLLOWING WHICH 2.5 X 12 MM SHOCKWAVE IVL BALLOON COULD BE PUSHED TO THE DESIRED SITE. THE SHOCKWAVE IVL BALLOON WAS INFLATED @ 4 ATMOSPHERE (ATM) AND TWO CYCLES OF 10 PULSES EACH WERE DELIVERED TO TWO ADJACENT CALCIFIED AREAS IN DISTAL RCA. POST PULSE THERAPY, WHEN THE IVL BALLOON WAS INFLATED AT 6 ATM TO CHECK FOR LESION MODIFICATION, THE BALLOON RUPTURED WITH TYPE B ARTERIAL DISSECTION WHICH WAS COVERED UNEVENTFULLY WITH 3.0 X 26 MM SIROLIMUS ELUTING STENT ((B)(4)) IN MID TO DISTAL RCA. IN PROXIMAL RIGHT CORONARY ARTERY (RCA), A 3.0 X 12 MM SHOCKWAVE IVL BALLOON WAS USED FOR LITHOPLASTY. HOWEVER, AT EIGHTH PULSE OF SECOND CYCLE, THE SECOND IVL BALLOON ALSO RUPTURED WITH DISTAL EMBOLIZATION OF BALLOON CONTENTS. THE PULSE WAVE THERAPY WAS IMMEDIATELY ABANDONED, AND CHECK ANGIOGRAM REVEALED NO ARTERIAL DISSECTION OR PERFORATION. THE LESION WAS FURTHER MODIFIED USING 3 X 12 MM NON-COMPLIANT (NC) BALLOON AND STENTED WITH 3.5 X 30 MM SIROLIMUS ELUTING STENT (ORSIROTM, BIOTRONIK AG). THE STENT ANGIOPLASTY WAS OPTIMIZED USING 3.5 X 12 AND 3.75 X 12 MM NC BALLOONS WITH AN ACCEPTABLE FINAL RESULT. THE PATIENT WAS DISCHARGED ON DAY 03 OF PROCEDURE ON DUAL ANTIPLATELETS DRUGS AND HAS COMPLETED AN UNEVENTFUL CLINICAL FOLLOW UP OF 04 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914214 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC C2IVL3012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other