BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER

    MDR report key: 23619720 · Received November 21, 2025

    Report

    Report Number
    3015053858-2025-00142
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    November 2, 2025
    Report Date
    June 3, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00195451000546
    PMA / PMN Number
    K240225
    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. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL MALFUNCTION REPORTED. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EVENT THAT OCCURRED DURING OR AFTER THE 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 DISRUPT PAD JAPAN STUDY. ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) IDENTIFIED STENOTIC LESIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND ANTERIOR TIBIAL ARTERY (ATA) WITH SEVERE CALCIFICATION; A FILTRAP II 8.0 MM FILTER WAS PLACED IN THE POPLITEAL ARTERY BECAUSE RESIDUAL STENOSIS >50% WAS ANTICIPATED AFTER BALLOONING. SFA TREATMENT INCLUDED JETSTREAM ATHERECTOMY (2.4/3.4 MM), IVUS-GUIDED DETECTION OF PARTIAL THROMBUS WITH SUBSEQUENT ASPIRATION, FOLLOWED BY PLAIN OLD BALLOON ANGIOPLASTY (POBA) (APERTA NSE 7.0 × 40 MM) AND DRUG-COATED BALLOON ANGIOPLASTY (RANGER 7.0 × 60 MM); THE FILTRAP WAS THEN REMOVED. ATA TREATMENT INVOLVED WIRE EXCHANGE TO VASSALLO 14 (300 CM), POBA WITH A 2.0 × 40 MM BALLOON, AND INTRAVASCULAR LITHOTRIPSY (SHOCKWAVE 3.0 × 80 MM). A SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED LESION IN THE FEMOROPOPLITEAL ARTERY. A TOTAL OF 400 IVL PULSES WERE SUCCESSFULLY DELIVERED. IVUS REVEALED INSUFFICIENT EXPANSION IN SOME AREAS; THEREFORE, ADDITIONAL POBA WAS PERFORMED USING A #14 SHIDEN HP 3.0 MM × 200 MM BALLOON. FINAL IVUS AND ANGIOGRAPHY CONFIRMED SATISFACTORY BLOOD FLOW, AND THE PROCEDURE WAS COMPLETED. TWO DAYS AFTER THE INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED FROM THE CLINICAL SITE. SIX DAYS AFTER THE INDEX PROCEDURE, THE SUBJECT PASSED AWAY DUE TO UNKNOWN CAUSES. THE INVESTIGATOR STATED THAT THE CAUSE OF DEATH HAS NOT BEEN DETERMINED THEREFORE THE CASUAL RELATIONSHIP BETWEEN THE IVL CATHETER AND THE PATIENT DEATH CANNOT BE ASSESSED. THERE WAS NO IVL MALFUNCTION REPORTED. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EVENT THAT OCCURRED DURING OR AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 14MAY2026: BASED ON THE LIMITED INFORMATION AVAILABLE, THE INVESTIGATOR UPDATED THE CAUSALITY ASSESSMENT AND DETERMINED THAT THE EVENT WAS NOT RELATED TO THE IVL GENERATOR, IVL CATHETER, OR THE PROCEDURE. THE DEATH IS MORE LIKELY ATTRIBUTABLE TO THE PATIENT'S UNDERLYING MEDICAL CONDITIONS, INCLUDING CRITICAL LIMB ISCHEMIA, DYSLIPIDEMIA, CHRONIC KIDNEY DISEASE, ISCHEMIC HEART DISEASE, THORACIC AORTIC ANEURYSM, ABDOMINAL AORTIC ANEURYSM, AS WELL AS THE PATIENT'S AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077457 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER PPN SHOCKWAVE MEDICAL, INC. E8IVL030080 17B241018A 00195451000546

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death #14 SHIDEN HP 3.0 MM × 200 MM BALLOON| 2.0 MM × 40 MM BALLOON - UNKNOWN MANUFACTURER| APERTA NSE PTA 7.0 MM × 40 MM| FILTRAP II 8.0 MM FILTER| JETSTREAM 2.4/3.4 MM| VASSALLO 14, 300 CM