BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 19784285 · Received July 19, 2024

    Report

    Report Number
    3015053858-2024-00074
    Event Type
    Death
    Date Received
    July 19, 2024
    Date of Event
    February 21, 2024
    Report Date
    July 19, 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
    PA, 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 THE STENT THROMBOSIS AND SUBSEQUENT DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL MALFUNCTION REPORTED. THE CEC HAS DETERMINED THAT THE STENT THROMBOSIS AND DEATH ARE POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLE TO THE PROCEDURE. THE CEC INDICATED THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE PROBABLE STENT THROMBOSIS AND THAT THE CARDIAC DEATH OCCURRED WITHIN 2 WEEKS OF THE INDEX PROCEDURE. 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

    THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY CATHETER WAS USED TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY. THE IVL CATHETER SUCCESSFULLY DELIVERED 50 PULSES AND THERE WAS NO DEVICE MALFUNCTION REPORTED. THE PATIENT PRESENTED 2 WEEKS POST-OP WITH A STENT THROMBOSIS AND SUBSEQUENTLY EXPIRED 15 DAYS AFTER THE INDEX PROCEDURE. THIS EVENT WAS SENT TO THE CLINICAL EVENTS COMMITTEE (CEC) FOR ADJUDICATION OF THE STENT THROMBOSIS AND DEATH. THE CEC HAS DETERMINED THAT THE STENT THROMBOSIS AND DEATH ARE POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLE TO THE PROCEDURE. THE CEC INDICATED THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE PROBABLE STENT THROMBOSIS AND THAT THE CARDIAC DEATH OCCURRED WITHIN 2 WEEKS OF THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754682 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL3512 02A230814A 00195451000003

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Death 4.0 X 12 POST-STENT DILATATION CATHETER - UNKNOWN| 4.0 X 12 PRE-DILATATION CATHETER - SPRINTER NC| 5.0 X 8 POST-STENT DILATATION CATHETER - UNKNOWN| SYNERGY XD MONORAIL DRUG ELUTING STENT