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

Model Number	C2AIVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
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 nstemi 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.
Event or Problem Description
This event was reported to shockwave via the pre-market forward cad ide study.Three investigational shockwave javelin coronary (artemis) intravascular lithotripsy (ivl) catheters and two non-investigational shockwave c2 aero coronary ivl catheters were used during an ivl procedure on (b)(6) 2026.This report documents the adverse event reported in association with the use of the two shockwave c2 aero coronary ivl catheters.It was reported that the patient experienced chest pain following the procedure and had a transient hypotensive episode with blood pressure readings of 84/61 mmhg and 76/53 mmhg, which resolved spontaneously.The initial post-procedure ecg (electrocardiogram) demonstrated a nonspecific st segment abnormality, while subsequent second and third ecgs showed inferior st segment elevation.The patient was taken to the catheterization laboratory (cath lab), where a diagnostic coronary angiogram was performed.Upon the patient's return from the cath lab, study mandated cardiac biomarkers were collected per protocol, as 12 hours had elapsed since the index procedure.Results showed: ck mb (creatine kinase-myocardial band): 25.1 ng/ml (upper limit of normal (uln): 7.8 ng/ml) troponin t hs (high sensitivity troponin t): 248 ng/ml (uln: 15 ng/ml) the patient was administered nitroglycerin 0.4 mg (sublingual), morphine 4 mg (iv), and metoprolol tartrate 5 mg (iv) to treat the adverse event.The patient denied chest pain after the procedure and at discharge.There was no ivl device malfunction reported, and the patient was discharged on (b)(6) 2026.The clinical study site determined that the non-st elevation myocardial infarction (nstemi) was possibly related to the study devices and definitely related to the procedure.This report is for the second catheter used in the procedure.The first catheter is being reported in mdr #3015053858-2026-00033.
Additional Manufacturer Narrative
Additional information received on 03apr2026 was added to section b5.
Event or Problem Description
Post-procedure, after use of three shockwave javelin devices, the lesion remained heavily calcified, and angiographic imaging demonstrated approximately 60% residual stenosis.After deciding that the severely calcified lesion needed further modification, it was decided to use a shockwave c2 aero catheter.The physician started with a 2.5mm shockwave c2 aero catheter and then used a 3.0mm shockwave c2 aero catheter.It was reported that the reason for the second c2 aero was further modification of the lesion.After the c2 aero catheters were used, two angiographic images were performed demonstrating a 20% residual stenosis.Overall, shockwave lithotripsy reduced the residual stenosis from 60% postjavelin to 20% postc2 aero.The lesion modification allowed for adequate stent expansion, and subsequent postdilation allowed full stent expansion.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO 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: 24781077
• Report Number: 3015053858-2026-00034
• Device Sequence Number: 17675551
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• UDI-Public: (01)00195451000607(17)271231(10)11A260106A
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: C2AIVL3012
• Device Catalogue Number: C2AIVL3012
• Device Lot Number: 11A260106A
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2026
• 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
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American