BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 17050197 · Received June 2, 2023

    Report

    Report Number
    3015053858-2023-00034
    Event Type
    Death
    Date Received
    June 2, 2023
    Date of Event
    May 23, 2023
    Report Date
    May 24, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000095
    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 NOT RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE REPORTED EVENT, AFTER THE IVL BALLOON SUCCESSFULLY DELIVERED 80 PULSES. THE PERFORATION OCCURRED AFTER THE VESSEL WAS DILATED WITH A HIGH-PRESSURE BALLOON USED TO ADDRESS THE STENT MALPOSITION. WHEN THE PATIENT COMPLAINED OF NAUSEA, IVUS IMAGING WAS PERFORMED AND IT REVEALED BLEEDING AT THE PROXIMAL AND DISTAL ENDS OF THE STENT. SEVERAL ATTEMPTS WERE MADE TO TREAT THE DISSECTION, AND SEVERAL ACTIONS WERE TAKEN TO TRY AND STABILIZE THE PATIENT. HOWEVER, THE PATIENT EXPIRED. THE PHYSICIAN COMMENTED THAT THERE WAS NO CAUSAL RELATION BETWEEN IVL CATHETER AND THE VESSEL PERFORATION. 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 A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CIRCUMFERENTIAL CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD #6) ARTERY. ACCESS TO THE TARGET VESSEL WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. AFTER THE IVL BALLOON SUCCESSFULLY DELIVERED 80 PULSES, AN ULTIMASTER NAGOMI¿ SIROLIMUS ELUTING CORONARY STENT WAS IMPLANTED AND DILATED AT NOMINAL PRESSURE (11 ATMS). IT WAS OBSERVED THAT THERE WAS STENT MALPOSITION AT THE MID STENT, SO A HIGH-PRESSURE BALLOON WAS USED TO POST DILATE TO 18 ATMS WITHOUT POST IMPLANT IMAGING. IMMEDIATELY, THE PATIENT COMPLAINED OF NAUSEA AND IVUS IMAGING REVEALED BLEEDING AT THE PROXIMAL AND DISTAL ENDS OF THE STENT. THE PATIENT WAS PROVIDED CARDIOPULMONARY RESUSCITATION OR CARDIAC MASSAGE, PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) AND TRANSFUSED WITH 5.8 LITERS OF BLOOD. A PK PAPYRUS STENT WAS ALSO IMPLANTED HOWEVER, THE BLEEDING COULD NOT BE STOPPED. A RYUREI¿ PERFUSION CATHETER WAS USED AND TWO MORE PAPYRUS STENTS WERE IMPLANTED TO STOP THE BLEEDING. ALSO, AN INTRABULLOUS ADHESION PEXIA (IBAP) WAS ALSO PERFORMED, HOWEVER, THE BLEEDING COULD NOT BE STOPPED. IT WAS REPORTED THAT ALTHOUGH THE ASCENDING AORTA AND AORTA ARCH WERE FINE, THE DISSECTION WAS OBSERVED AT THE DESCENDING AORTA WHERE THE IBAP WAS PERFORMED BUT BLEEDING WAS ALSO OBSERVED AT THE RIGHT WALL OF A PREVIOUS TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). SEVERAL HOURS LATER, THE PATIENT EXPIRED. THE PHYSICIAN COMMENTED THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE IVL CATHETER AND THE VESSEL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371939 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 A220404B 00195451000095

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death PK PAPYRUS CORONARY STENT - BIOTRONIK| RYUREI¿ PERFUSION CATHETER - TERUMO| ULTIMASTER NAGOMI¿ SIROLIMUS ELUTING CORONARY STEN