MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER

Model Number	E8IVL060080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported from the shockwave disrupt pad japan study.A shockwave e8 peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the femoropopliteal artery.The first ivl catheter used broke while attempting to insert the device.The device did not enter the patient and no pulses were delivered.A second shockwave e8 peripheral ivl catheter was used and 400 ivl pulses were successfully delivered to the target lesion.Four days post-procedure, a superficial femoral artery (sfa) acute occlusion was observed, and the patient was readmitted to the hospital.The patient reported sudden numbness and coldness in the left lower leg.Two days later, the patient underwent thrombectomy, and target lesion revascularization of the left sfa, followed by a stent placement.The principal investigator confirmed that blood flow to the lower limb improved significantly.The patient was discharged three days after.(this event was previously reported via mdr# 3015053858-2025-00110.) on (b)(6) 2026, five (5) months post index procedure, the patient was admitted to the hospital due to a report of sudden numbness and a cold sensation in the lower left leg.An angiogram revealed a separate event of superficial femoral artery (sfa) acute occlusion.The next day, the patient underwent thrombectomy, and target lesion revascularization of the left sfa.Angiograms were performed and revealed that the blood flow had improved, and the patient was discharged ten (10days) later.(the second occurrence of occlusion is being reported via mdr# 3015053858-2026-00010.) there was no additional patient sequalae reported.The clinical site determined that the second occurrence of occlusion was possibly related to the second ivl device and procedure.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.While the first ivl catheter used broke upon insertion, no ivl pulses were delivered to the patient and is therefore not related to the occlusion.There was no ivl device malfunction reported on the second or third catheter used.The cause of the occlusions could not be definitively determined based on the information available.The clinical site determined that the second occurrence of occlusion was possibly related to the second ivl catheter and possibly related to the procedure.Shockwave medical safety determined that the second occurrence occlusion was not related to the device and possibly related to 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.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): SHOCKWAVE MEDICAL, INC; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 24264441
• Report Number: 3015053858-2026-00010
• Device Sequence Number: 10021681
• Product Code: PPN
• UDI-Device Identifier: 00195451000584
• UDI-Public: (01)00195451000584(17)270131(10)01B250123A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K240225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: E8IVL060080
• Device Catalogue Number: E8IVL060080
• Device Lot Number: 01B250123A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT - MANUFACTURER UNKNOWN
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic