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

Model Number	C2PIVL2512
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Angina (1710); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Restenosis (4576)
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.Based on the reported information, no information was provided suggesting the ivl device contributed to the stemi - very late stent thrombosis.There was no reported ivl catheter issue.Per the reporter, the relationship to the study device and study procedure are both possible.Swmi medical safety and chief medical officer assessed the stent thrombosis > 1 year post index procedure as unrelated to ivl use, and highly unlikely to be related to the index procedure, and is often an unpredictable consequence of any coronary intervention.The event occurred >1 year post ivl, which raises the suspicion that this event may have been related to discontinuation of dual anti-platelet therapy (dapt) & reversion to single antiplatelet therapy (sapt).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.Complaint trends will continue to be monitored.
Event or Problem Description
This event was reported from the shockwave post market empower cad study.The date of subject's index procedure was on (b)(6) 2024.The subject had a lesion with 90% stenosis and moderate calcification.Pre-dilatation was performed using scoring/cutting balloons but was unsuccessful in dilating the lesion.Subsequently, post-dilatation was carried out following the use of shockwave c2+ coronary intravascular lithotripsy (ivl) catheter.A medtronic onyx frontier rx drug-eluting stent (des) was successfully delivered to target lesion (tl1) during the index procedure.Post-stent dilation was performed, achieving a final residual stenosis was 0%.The subject's angina symptoms began on (b)(6) 2025, and she presented to the emergency department the same day.Subsequently, the subject was transported to an outside hospital for cardiac catheterization.The subject underwent left heart catheterization, revealing a 100% occlusion of the left anterior descending artery (lad) stent, along with a large clot burden.The patient underwent clot thrombectomy and balloon angioplasty of the previously deployed lad stent.Findings included a moderately severe lesion in the right ventricle (rv) and mild in-stent restenosis in the right coronary artery (rca).The subject was restarted on plavix 75mg and was advised to wear a lifevest by cardiology.The subject was discharged home in stable condition on (b)(6) 2025.Per the reporter, the relationship to the study device and study procedure are both possible.

• 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: 22878096
• Report Number: 3015053858-2025-00100
• Device Sequence Number: 5752911
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: 08/22/2025
• 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: BALLOON - UNKNOWN MANUFACTURER.; MEDTRONIC ONYX FRONTIER DRUG-ELUTING STENT (DES).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White