BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 11809611 · Received May 11, 2021

    Report

    Report Number
    3015053858-2021-00006
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 14, 2021
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    QMG
    UDI-DI
    00195451000102
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON FOLLOW-UP INFORMATION RECEIVED FROM THE PHYSICIAN, IT IS SUSPECTED THAT THE VESSEL MIGHT HAVE BEEN PERFORATED WITH THE MULTIPLE USAGE OF GUIDEWIRES IN CONJUNCTION WITH THE SYNERGY STENT THAT MAY HAVE BEEN OVERSIZED FOR THE VESSEL IN THE PRESENCE OF CALCIUM. IT WAS NOTED THAT A SYNERGY 3.5MM STENT WAS IMPLANTED WHERE A 3.0MM WOULD HAVE BEEN MORE SUITABLE. HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED WITHOUT IMAGES CONFIRMING WHEN THE PERFORATION OCCURRED. OVERALL, THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE, AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. 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

    A SHOCKWAVE C2 3.5MM X 12MM INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A COMPLETE OCCLUSION (CTO) OF THE RIGHT CORONARY ARTERY (RCA). THE PROCEDURE WAS DONE WITH LOCAL ANESTHESIA VIA ANTEGRADE RETROGRADE ACCESS THROUGH THE SEPTAL BRANCHES, AND VERY SMALL VESSELS (~1MM). IT WAS NOTED THAT IT TOOK THE PHYSICIAN OVER TWO (2) HOURS TO CROSS THE LESION, AND MULTIPLE ACCESSORY DEVICES WERE USED DURING THE WHICH INCLUDED A STINGRAY DEVICE, MULTIPLE CROSSING WIRES AND NON-COMPLIANT (NC) BALLOONS. THE SHOCKWAVE DEVICE APPEARED TO SUCCESSFULLY YIELD THE LESION. FOLLOWING IVL TREATMENT, 'CAPTURE' WAS OBSERVED AND A DROP IN BLOOD PRESSURE INDICATING A PERFORATION OF THE VESSEL, AND THE PHYSICIAN PROCEEDED WITH THE PLACEMENT OF A SYNERGY STENT (BOSTON SCIENTIFIC'S DRUG ELUDING STENT). THE BALLOON PRESSURE TO DELIVER THE SYNERGY STENT IS UNKNOWN. AT THAT TIME A PERFORATION WAS OBSERVED, FOLLOWING THE PLACEMENT OF THE STENT. IT WAS NOTED THAT DUE TO THE CHALLENGING ACCESS AND VIEW, IMAGES COULD NOT BE TAKEN AFTER IVL AND BEFORE THE SYNERGY STENT PLACEMENT TO CONFIRM WHEN THE PERFORATION OCCURRED. THE PHYSICIAN ELECTED TO PLACE FIVE (5) COVERED STENTS (PAPYRUS - BIOTRONIK, INC) AT THE LOCATION OF THE PERFORATION, WITH RESIDUAL STAINING OBSERVED. BASED ON FOLLOW-UP INFORMATION RECEIVED FROM THE PHYSICIAN, IT IS SUSPECTED THAT THE VESSEL MIGHT HAVE BEEN PERFORATED WITH THE MULTIPLE USAGE OF GUIDEWIRES IN CONJUNCTION WITH THE SYNERGY STENT THAT MAY HAVE BEEN OVERSIZED FOR THE VESSEL IN THE PRESENCE OF CALCIUM. IT WAS NOTED THAT A SYNERGY 3.5MM STENT WAS IMPLANTED WHERE A 3.0MM WOULD HAVE BEEN MORE SUITABLE. HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED WITHOUT IMAGES CONFIRMING WHEN THE PERFORATION OCCURRED. OVERALL, THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE, AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706221 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC C2IVL3512 P210120B 00195451000102

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention