BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER

    MDR report key: 25340763 · Received May 29, 2026

    Report

    Report Number
    3015053858-2026-00051
    Event Type
    Death
    Date Received
    May 29, 2026
    Date of Event
    May 21, 2026
    Report Date
    May 29, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000607
    PMA / PMN Number
    P200039/S015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 BALLOON LOSS OF PRESSURE, DISSECTION, PERFORATION, CHEST PAIN, LOSS OF BLOOD, CARDIAC TAMPONADE, AND SUBSEQUENT PATIENT DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. REVIEW OF THE EVENT BY SHOCKWAVE MEDICAL SAFETY DETERMINED THAT THE EVENT IS DEVICE AND PROCEDURE RELATED. THE BALLOON RUPTURE MAY HAVE CONTRIBUTED TO VESSEL INJURY; HOWEVER, CORONARY PERFORATION IS A KNOWN RISK OF CATHETER-BASED INTERVENTIONS. 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 C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERY. IT WAS REPORTED THAT A PATIENT UNDERWENT A ROUTINE RADIAL HEART CATHETERIZATION WITH INTRAVASCULAR ULTRASOUND (IVUS) WHICH IDENTIFIED A CONCENTRIC LESION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A VESSEL DIAMETER OF 3.1 MM WITH CALCIFICATION. IN THE FIRST PROCEDURE, A 6F RADIAL SHEATH AND EXTRA BACKUP (EBU) 3.5 GUIDE WERE USED, WITH A 014 OMNI WIRE PLACED ACROSS THE MID-LAD AND SHOWED POSITIVE FRACTIONAL FLOW RESERVE (FFR). AFTER REMOVING THE 014 OMNI WIRE, A 014 RUNTHROUGH WIRE WAS ADVANCED ACROSS THE LESION. A 3.0X24 NON-COMPLIANT (NC) BALLOON WAS INFLATED TO NOMINAL PRESSURE. A PROPERLY PREPPED 3.0X12MM C2 AERO IVL CATHETER WAS PLACED AND CROSSED SUCCESSFULLY, BUT THE IVL BALLOON RUPTURED AFTER TWO CYCLES (20 PULSES) AT 4 ATMS. FOLLOWING THE IVL PROCEDURE, A TYPE 3 DISSECTION (MEASURING 20MM IN LENGTH) AND CORONARY PERFORATION WAS OBSERVED. A 3.0X38 DRUG-ELUTING SYNERGY STENT WAS DEPLOYED, FOLLOWED BY POST-DILATION WITH 3.0 AND 4.0 NC BALLOONS. REPEAT IVUS AT THAT TIME SHOWED A GOOD RESULT AND THE PATIENT WAS INITIALLY STABLE. SHORTLY AFTER RETURNING TO THE ROOM, THE PATIENT DEVELOPED CHEST PAIN AND WAS BROUGHT BACK TO THE CATHETERIZATION LAB, WHERE THE PATIENT UNDERWENT A SECOND PROCEDURE. A 7F FEMORAL SHEATH WAS INSERTED WITH A 7F EBU 3.75 GUIDE; A 014 RUNTHROUGH WIRE WAS AGAIN ADVANCED. IVUS INDICATED ONGOING DISSECTION AND PERFORATION, AND THE PATIENT BEGAN EXHIBITING SIGNS OF CARDIAC TAMPONADE. THREE COVERED PAPYRUS STENTS (4.0X20, 3.5X20, 3.5X15) WERE PLACED FROM THE PROXIMAL TO DISTAL PORTIONS OF THE LAD, FOLLOWED BY INFLATIONS WITH 4.0 AND 4.5 NC BALLOONS AND POST-IVUS ASSESSMENT. DESPITE THESE EFFORTS, THE PERFORATION REMAINED UNSEALED AND THE PATIENT DID NOT IMPROVE. THE PATIENT PROCEEDED TO EMERGENCY SURGERY FOR A MEDIAN STERNOTOMY TO EVACUATE BLOOD FROM AROUND THE HEART, AND TO RELIEVE PERICARDIAL BLEEDING AND CARDIAC TAMPONADE. AN IMPELLA DEVICE WAS INSERTED, WHICH EVACUATED 1200 ML OF BLOOD AND RETURNED 235 ML. THE PATIENT PASSED AWAY SHORTLY AFTER SURGERY ON (B)(6) 2026, WITH THE CAUSE OF DEATH DETERMINED TO BE CORONARY PERFORATION AND CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523707 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2AIVL3012 02A260223A 00195451000607

    Patients

    Seq Age Sex Outcome Treatment
    1