MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (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	12/11/2023
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 (rca).10 pulses were successfully delivered at a max of 6 atm.There was no ivl malfunction reported.Prior to the procedure, the patient's creatine kinase-mb (ck-mb) was measured at normal baseline level.Within forty-eight (48) hours after the procedure, the patient's cm-mb levels became elevated to 100 times the upper normal limit (uln).The patient was discharged.This event was adjudicated by the clinical events committee (cec) which confirmed a non q-wave myocardial infarction was attributable to the target vessel.The cec noted loss of side branches in the rca as well as st elevation in inferior leads post-index procedure.It was determined that the mi was possibly related to the study device and definitely related to the 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 root cause of the myocardial infarction could not be definitively determined based on the information available.There was no ivl malfunction reported.The cec determined that the mi was possibly related to the study device and definitely related to the 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.

• 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 95054
• Manufacturer (Section G): SHOCKWAVE MEDICAL, INC; 5403 besty ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara 95054
• MDR Report Key: 21330059
• Report Number: 3015053858-2025-00015
• Device Sequence Number: 12935804
• Product Code: QMG
• UDI-Device Identifier: 00195451000034
• UDI-Public: (01)00195451000034(17)250731(10)04A230714A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: 07/31/2025
• Device Model Number: C2PIVL4012
• Device Catalogue Number: C2PIVL4012
• Device Lot Number: 04A230714A
• 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: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRUG ELUDING STENT - MEDTRONIC ONYX FRONTIER; NON-COMPLIANT BALLOON FOR POST-DILATATION - SPRINT; NON-COMPLIANT BALLOON FOR PRE-DILATATION - EUPHORA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic