BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 19933885 · Received August 7, 2024

    Report

    Report Number
    3015053858-2024-00091
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 7, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000003
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 CHEST PAIN AND DISSECTION COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL MALFUNCTION REPORTED. THE PHYSICIAN ATTRIBUTED THE COMPLICATION TO A DISSECTION IN THE LM. THE DISSECTION WAS TREATED WITH A BALLOON AND STENT. NOTABLY, THE LESION TREATED INITIALLY WITH SHOCKWAVE THERAPY WAS APPROXIMATELY 40-50MM AWAY FROM THE DISSECTION SITE. 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 CORONARY C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). 90 PULSES WERE DELIVERED AT PRESSURES OF 4 TO 6 ATM. A 2.5X48MM SYNERGY STENT WAS PLACED AND POST-DILATED WITH A 3.0 NON-COMPLIANT (NC) BALLOON. THE FINAL IMAGING SHOWED SUCCESSFUL RESULTS. THERE WAS NO REPORTED IVL MALFUNCTION. 30 MINUTES POST PROCEDURE, THE PATIENT WAS COMPLAINING OF SEVERE CHEST PAIN. MEDS WERE GIVEN TO HELP WITH THE PAIN AND VITALS APPEARED GOOD, BUT THE PAIN INCREASED TO 10/10. THE PHYSICIAN CHOSE TO PROCEED WITH RIGHT GROIN ACCESS TO PERFORM ANOTHER ANGIOGRAM. LUCENCY WAS OBSERVED IN DISTAL LEFT MAIN (LM) AT THE LAD/CIRCUMFLEX (CX)BIFURCATION AND A RE-INTERVENTION WAS INITIATED. BOTH CX AND LAD WERE WIRED USING A 3.0X15MM BALLOON TO PRE-DILATE THE LESION ON THE LAD WIRE AT DISTAL LM AND THEN THE BALLOON WAS RETURNED TO PRE-DILATE LM-PROXIMAL CX. A 3.0X20MM SYNERGY STENT WAS PLACED IN THE PROXIMAL CX AND POST DILATED WITH A 3.0X20 NC BALLOON. A 3.5X20MM SYNERGY STENT WAS THEN PLACED FROM LM TO PROXIMAL LAD AND POST DILATED LM WITH A 4.5X15 NC BALLOON. THE PATIENT'S BLOOD PRESSURE DROPPED NECESSITATING THE USE OF IMPELLA SUPPORT. ONCE ON IMPELLA SUPPORT, 3.0X15 BALLOONS WERE PLACED OVER EACH WIRE TO DO A "KISSING" TECHNIQUE AT BIFURCATION. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS THEN UTILIZED TO CHECK STENT APPOSITION AND CONFIRMED ALL STENTS WERE WELL APPOSED AND EXPANDED. FINAL IMAGING SHOWED GOOD RESULTS. THE PHYSICIAN ATTRIBUTED THE COMPLICATION TO A DISSECTION IN THE LM. THE DISSECTION WAS TREATED WITH A BALLOON AND STENT. NOTABLY, THE LESION TREATED INITIALLY WITH SHOCKWAVE THERAPY WAS APPROXIMATELY 40-50MM AWAY FROM THE DISSECTION SITE. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE ICU ON IMPELLA SUPPORT. THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535003 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL2512 11A230713A 00195451000003

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Other 2.5X48MM SYNERGY STENT - UNKNOWN MANUFACTURER| 3.0MM NC BALLOON - UNKNOWN MANUFACTURER| 3.0X15MM NC BALLOON - UNKNOWN MANUFACTURER| 3.0X20MM NC BALLOON - UNKNOWN MANUFACTURER| 3.0X20MM SYNERGY STENT - UNKNOWN MANUFACTURER| 3.5X20MM SYNERGY STENT - UNKNOWN MANUFACTURER| 4.5X15MM NC BALLOON - UNKNOWN MANUFACTURER| IMPELLA HEART PUMP - ABIOMED