MAUDE Adverse Event Report: 3. MANUFACTURER NAME, CITY AND STATE SHOCKWAVE MED SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	C2PIVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to shockwave via the post market empower cad clinical study.On (b)(6) 2024, a shockwave c2+ intravascular lithotripsy (ivl) catheter was used to treat a patient undergoing a left heart catheterization (lhc) with percutaneous coronary intervention (pci) to the mid left descending artery (lad).It was reported that a spiral dissection and occlusion occurred in the mid lad during ivl, which was treated with the placement of multiple (4) drug eluting stents (des).Following deployment of the des, it was observed that the mid-lad septal branch was compromised and the patient experienced chest pain during and after the index procedure, necessitating the use of nitroglycerin drip (ntg gtt) for pain management.The patient was admitted to the critical care unit for further monitoring and treatment and was released three (3) days following the index procedure.There was no report of an ivl device malfunction.The clinical site has determined that the relationship of the dissection and subsequent chest pain to both the study device and procedure was causal/ definite.
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 dissection and subsequent occlusion and chest pain could not be definitively determined based on the information available.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.Complaints will continue to be monitored for trending purposes.
Additional Manufacturer Narrative
The cause of the myocardial infarction, and previously reported dissection, occlusion, and chest pain could not be definitively determined based on the information available.The following sections were updated per additional information received on 09apr2026.B5: added new information recevied on 09apr2026.H6: added annex e: 1969.H6: replaced annex f: 4614 with 4617.H6: added annex f: 4644 and 4621.
Event or Problem Description
This event was reported to shockwave via the post market empower cad clinical study.On (b)(6) 2024, a shockwave c2+ intravascular lithotripsy (ivl) catheter was used to treat a patient undergoing a left heart catheterization (lhc) with percutaneous coronary intervention (pci) to the mid left descending artery (lad).It was reported that a spiral dissection and occlusion occurred in the mid lad during ivl, which was treated with the placement of multiple (4) drug eluting stents (des).Following deployment of the des, it was observed that the mid-lad septal branch was compromised and the patient experienced chest pain during and after the index procedure, necessitating the use of nitroglycerin drip (ntg gtt) for pain management.The patient was admitted to the critical care unit for further monitoring and treatment and was released three (3) days following the index procedure.This information was previously reported via mdr 3015053858-2024-00111.On (b)(6) 2026 shockwave medical inc received notification that an adjudication performed by the clinical evaluation committee on (b)(6) 2024 found that a myocardial infarction (mi) occurred along with dissection, occlusion and chest pain on same day as the index procedure.The clinical site has determined that the relationship of mi to both the study device and procedure was definite.

• Brand Name: SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): 3. MANUFACTURER NAME, CITY AND STATE SHOCKWAVE MED; 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: 20326891
• Report Number: 3015053858-2024-00111
• Device Sequence Number: 7630748
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)250831(10)01A230814A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P200039
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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 Expiration Date: 08/31/2025
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 01A230814A
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female