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

Model Number	C2PIVL4012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	09/02/2024
Type of Reportable Event	Death
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 patient's heart attack and subsequent death could not be definitively determined based on the information available.There was no ivl device malfunction reported.Review of the event by shockwave medical safety and medical affairs determined that the death was not related to the study device or procedure as the event occurred more than a month post index 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.On (b)(6) 2024, a shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the distal left main coronary artery.The patient underwent a percutaneous coronary intervention (pci) procedure for treatment for non-st elevation acute coronary syndrome (nste-acs).The target lesion was accessed with a 6 french guide catheter (6f) via the femoral artery and was pre-dilated with a non-compliant (nc) balloon, followed by the delivery of 120 ivl pulses at 4 atmospheres of pressure (atm).A stent was subsequently implanted, with post-dilation using an additional nc balloon.The patient was discharged one day after the index procedure.No ivl device malfunction occurred during the procedure.On (b)(6) 2024, approximately 40 days after the index procedure, it was reported that the patient died at home from a heart attack.No additional information was provided.The clinical study site determined that the death was possibly related to the study device and procedure.
Event or Problem Description
Additional information was received on april 9, 2026, reporting that there is no information regarding the cause of death.The event was classified as a cardiac death, specifically an unwitnessed death and death of unknown cause.
Additional Manufacturer Narrative
Information received on 09apr2026 was added to section b5.

• 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: 24397590
• Report Number: 3015053858-2026-00017
• Device Sequence Number: 8289602
• Product Code: QMG
• UDI-Device Identifier: 00195451000034
• UDI-Public: (01)00195451000034(17)251130(10)01A231108A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 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): 04/17/2026

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: 11/30/2025
• Device Model Number: C2PIVL4012
• Device Catalogue Number: C2PIVL4012
• Device Lot Number: 01A231108A
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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: 3.50 X 12 PRE-DILATION NC BALLOON BOSTON SCIENTIFIC; 4 X 12 POST-STENT DILATATION NC BALLOON - UNK MFR; 4.50 X 12 POST-DILATION NC BALLOON - ABBOTT; ONYX FRONTIER DRUG-ELUTING STENT - MEDTRONIC
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White