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

Model Number	C2PIVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Date of Event	05/25/2025
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 myocardial infarction and thrombosis could not be definitively determined based on the information available.There was no ivl device malfunction reported.The clinical site determined that the st-elevation myocardial infarction (stemi) stent thrombosis was possibly related to both the ivl device and the procedure.Shockwave medical safety determined that the event was not related to both the ivl device and the procedure because it occurred one year after the index ivl 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.
Event or Problem Description
This event was reported to shockwave via the post-market empower cad clinical study.A shockwave intravascular lithotripsy (ivl) coronary c2+ was used to treat a moderately calcified lesion in the mid left anterior descending artery (lad).A total of 100 ivl pulses were delivered at 6 atm.Multiple scoring/cutting balloons were used for pre and post dilatation.There was no reported ivl device malfunction.A year after the index procedure, the patient experienced angina symptoms.The patient presented to the emergency department on the same day and was transported to an outside hospital and underwent left heart catheterization with results of 100% occlusion of the lad stent.A large clot burden was observed and post clot thrombectomy was performed.Balloon angioplasty was performed of a previously deployed lad stent.There was a moderately severe lesion in the right ventricle (rv) and mild in-sent restenosis of the right coronary artery (rca).The patient was restarted on 75mg of plavix.Cardiology recommended a life vest for the patient.The patient was discharged in stable condition two days later.The clinical site determined that the st-elevation myocardial infarction (stemi) stent thrombosis was possibly related to both the ivl device and the procedure.

• 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: 23493531
• Report Number: 3015053858-2025-00127
• Device Sequence Number: 21094551
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)250930(10)06A230920A
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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: 09/30/2025
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 06A230920A
• 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: 08/01/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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: 2.0 X 15 BSCI NC EMERGE NR - PRE-DILATATION CATH.; 2.5 X 12 BSCI NC EMERGE MR - PRE-DILATATION CATH.; 2.5 X 15 BSCI NC EMERGE NR - PRE-DILATATION CATH.; 2.5 X 20 BSCI NC EMERGE MR - POST-DILATATION CATH.; 2.5 X 38 - ONYX FRONTIER RX DES; 2.75 X 12 POST-STENT DILATATION CATH. -UNKNOWN MFG; 6F GUIDE CATHETER - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White