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

Model Number	E8IVL050080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to shockwave via the pre market disrupt pad japan study involving a shockwave e8 peripheral intravascular lithotripsy (ivl) catheter.The patient was enrolled in a prospective, multi-center, single-arm investigational study to treat moderate and severely calcified femoropopliteal arteries.An anticoagulant (heparin) was administered during the index procedure and post-procedure.Antiplatelet therapy with aspirin and clopidogrel was recorded prior to the index procedure and remained ongoing.It was reported that the patient's medical history included hypertension, hyperlipidemia, current smoker, coronary artery disease, prior coronary stenting or bypass procedure, renal insufficiency requiring dialysis (last dialysis performed on (b)(6) 2025), cerebrovascular accident (most recent event >60 days prior; 2026), atrial fibrillation, respiratory/pulmonary disease, laryngeal cancer, endovascular therapy performed on the left superficial femoral artery (evt - lt sfa) with hospitalization within the past 60 days (b)(6) 2025), and peripheral procedures.On (b)(6) 2025, the subject underwent a successful index procedure for a target lesion in the right superficial femoral artery using a shockwave e8 peripheral ivl catheter.Post-procedure findings showed improved vessel patency with no dissection and no need for stenting.The subject was discharged on (b)(6) 2025 in stable condition with normal physical examination findings.Subsequent follow-ups at 30 days and 6 months demonstrated normal physical examinations and vital signs, with no abnormalities reported.On (b)(6) 2026, approximately 12 months after the index procedure, the patient was hospitalized for treatment for an unknown reason.No device malfunction has been reported, and no additional information about the patient's outcome was provided.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the patient's hospitalization for treatment approximately 12 months after the index procedure could not be definitively determined based on the information available.There was no ivl device malfunction reported.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 Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 94054 ; 8877754846
• MDR Report Key: 25564158
• Report Number: 3015053858-2026-00063
• Device Sequence Number: 10250129
• Product Code: PPN
• UDI-Device Identifier: 00195451000577
• UDI-Public: (01)00195451000577(17)260930(10)03B240920A
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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 Expiration Date: 09/30/2026
• Device Model Number: E8IVL050080
• Device Catalogue Number: E8IVL050080
• Device Lot Number: 03B240920A
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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: WIRE - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: Asian