MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

Model Number	C2PIVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)
Date of Event	12/18/2025
Type of Reportable Event	Death
Event or Problem Description
A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the mid-left anterior descending artery (lad) of a patient with complex coronary artery disease (left main lesion, heavily calcified lad lesions, and ctos of the circumflex and rca) who had previously undergone outside-hospital catheterization with placement of a left main des after being deemed a poor surgical bypass candidate due to pericardial calcification and suboptimal graft targets.He was readmitted with recurrent ischemic symptoms and taken to the cardiac catheterization lab via right femoral access without difficulty.Angiography was performed using a voda 4 guide and a runthrough wire to the lad; pre-dilation of the lad was performed with a euphora balloon, and ivus could not cross the lad but was performed in the left main, demonstrating a minimal lumen area of roughly 8 mm and areas of stent mal-apposition.Three resolute onyx drug eluting stents (des) were deployed to the distal and mid lad, and the previously placed 4.00×8 mm left main stent was post-dilated per ivus guidance with a noncompliant euphora balloon until the operator judged expansion adequate.Persistent under-expansion in the mid lad prompted use of a c2+ ivl catheter.The ivl pulses were delivered to the under-expanded segment of the stent, and then proximally.After ivl, angiography showed timi 1 flow in the treated area, and a fourth resolute onyx stent was placed; final angiography demonstrated timi 3 flow with no residual stenosis, and no evidence of edge dissection, perforation, or rupture.Shortly after the final angiogram the patient developed abrupt bradycardia and hypotension; full acls was initiated and continuous cpr was performed for over one hour, but the patient expired.The cause of death remains undetermined.There was no reported malfunction of the shockwave device.
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 death could not be definitively determined based on the information available.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 C2+ CORONARY IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY 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: 23918544
• Report Number: 3015053858-2025-00160
• Device Sequence Number: 9295655
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)270430(10)01A250401B
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 01A250401B
• 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: 12/18/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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: 0.014 180CM RUNTHROUGH GUIDE WIRE - TERUMO; 2.50X12MM EMERGE PTCA BALLOON - BOSTON SCIENTIFIC; 2.50X34MM RESOLUTE ONYX DES - MEDTRONIC; 2.50X38MM RESOLUTE ONYX DES - MEDTRONIC; 2.50X8MM RESOLUTE ONYX DES- MEDTRONIC; 2.75X15MM NC EUPHORA PTCA BALLOON - MEDTRONIC; 3.00X34MM RESOLUTE ONYX DES - MEDTRONIC; 4.50X6MM NC EUPHORA PTCA BALLOON - MEDTRONIC; 5FR GUIDE EXTENSION CATHETER - TELEFLEX; 6FR OPTICROSS IVUS IMAGING CATHETER - BOSTON SCI; 6FR VODA LEFT 4 GUIDE CATHETER - BOSTON SCIENTIFIC
• Outcome Attributed to Adverse Event: Other; Required Intervention; Death
• Patient Age: 79 YR
• Patient Sex: Male