MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	C2PIVL3012
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Chest Pain (1776); Myocardial Infarction (1969); Thromboembolism (2654)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to shockwave via the post market empower cad clinical study.A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the mid right coronary artery.70 pulses were successfully delivered at 10 atm, above the indicated pressure of 4 atm for ivl treatment per the device instructions for use.There was no ivl malfunction reported.After the procedure, the patient reported chest pain.Post-procedure labs also noted elevated troponin levels and no significant ekg changes.The clinical site determined that the myocardial infarction (mi) was not related to the study device and definitely related to the procedure.The pi evaluation noted concern for post pci non-st-elevation myocardial infarction (nstemi) from the distal embolization of the thrombus.The patient started on heparin ggt.The telemetry overnight report noted episodes of premature ventricular contractions (pvcs) and non-sustained ventricular tachycardia (nsvt).A day after the index procedure, the patient rated the chest pain a 1 out of 10.Troponin levels peaked and heparin was discontinued.The next day, prior to discharge, the patient confirmed no chest pain or other symptoms.This event was sent to the clinical events committee (cec) for adjudication of the myocardial infarction (mi).The cec determined that the mi was a non-q-wave mi attributable to the target vessel.They determined that the mi was possibly related to the study device and definitely related to the procedure.The troponin levels were greater than 70 x upper limit of normal (uln) within 48 hours of the index procedure.
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 myocardial infarction could not be definitively determined based on the information available.It was reported that 70 ivl pulses were successfully delivered at 10 atm, above the indicated pressure of 4 atm for ivl treatment per the device instructions for use; however, it could not be definitively determined whether this contributed to the event.There was no ivl 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 C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (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: 21300300
• Report Number: 3015053858-2025-00012
• Device Sequence Number: 20875291
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)260131(10)04A240129A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

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 Expiration Date: 01/31/2026
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 04A240129A
• 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: 01/09/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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: ONYX FRONTIER RX DES- 3.0 X 38 - MEDTRONIC.; ONYX FRONTIER RX DES- 3.0 X 38 - MEDTRONIC.; POST-DILATATION CATHETER - 1.5 X 15 - TERUMO.; POST-DILATATION CATHETER 2.0 X 12 - BSCI EMERGE MR.; POST-STENT DILATATION CATHETER 3.5 X 20 - UNKNOWN.; POSTDILATATION CATHETER 3.0 X20 -BSCI NC EMERGE MR.; PRE-DILATATION CATHETER 2.0 X 20 - BSCI EMERGE MR.; PRE-DILATATION CATHETER 2.0 X 20 - BSCI EMERGE MR.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Female