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

Model Number	C2PIVL3512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	11/26/2024
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 could not be definitively determined based on the information available.No device malfunction was reported.The site reported the cause of the myocardial infarction to be possibly related to the device and not related to the procedure.A review of the event by shockwave safety determined there is no plausible connection between ivl therapy or the procedure and an mi occurring approximately 5 months after 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.
Event or Problem Description
The following events were reported from the shockwave post market empower cad study.The subject underwent shockwave c2+ coronary intravascular (ivl) lithotripsy on (b)(6) 2024 via radial access with a 7f guide catheter following prior diagnostic catheterization revealing evidence of calcification.One target lesion was treated, with no non-target lesions addressed.The total procedure time was approximately 2 hours, and the total fluoroscopy time of 54 minutes.One (1) day post-index procedure, the patient experienced right forearm hematoma.This event was successfully resolved by compression using a blood pressure (bp) cuff and the swelling stabilized.It was determined to be unrelated to the device and probably related to the procedure.The 30d and 12m routine follow-ups were uneventful.Four (4) months post-index procedure, the patient presented the hospital with non-st-segment elevation myocardial infarction (nstemi) determined by the site to be possibly related to the device and not related to the procedure.This event was successfully resolved with additional intervention.
Event or Problem Description
On (b)(6) 2026, the event was sent to the clinical events committee (cec) for adjudication of the patient's non-st-segment elevation myocardial infarction (nstemi), and it was determined by the site as not related to the device and possibly related to the procedure.
Additional Manufacturer Narrative
Per the cec, the relationship to the study device is not related, and the relationship to the study procedure is possibly related.Per new information received 07jan2026, section b5 was updated to add the following verbiage: "on (b)(6) 2026, the event was sent to the clinical events committee (cec) for adjudication of the patient's non-st-segment elevation myocardial infarction (nstemi), and it was determined by the site as not related to the device and possibly related to 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: 23539318
• Report Number: 3015053858-2025-00135
• Device Sequence Number: 18473387
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)251231(10)01A231212A
• Combination Product (Y/N): N
• 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): 01/20/2026

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: 12/31/2025
• Device Model Number: C2PIVL3512
• Device Catalogue Number: C2PIVL3512
• Device Lot Number: 01A231212A
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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: POST-DIL. BALLOON - 3.00 X 12MM - EMERGE MONORAIL.; POST-DILATATION BALLOON - 2.00 X 12MM - MINI TREK.; POST-DILATATION BALLOON - 2.50 X 15MM - NC EUPHORA.; POST-DILATATION BALLOON - 3.50 X 8MM - NC EUPHORA.; POST-DILATATION BALLOON - 3.50 X 8MM - UNKNOWN MFR.; POST-DILATATION BALLOON - 3.50 X 8MM - UNKNOWN MFR.; POST-DILATATION BALLOON - 4.00 X 8MM - UNKNOWN MFR.; PRE-DIL. BALLOON - 1.00 X 10MM - SAPPHIRE II PRO.; PRE-DILATATION BALLOON - 1.50 X 12MM - TAKERU.; PRE-DILATATION BALLOON - 2.00 X 12MM - MINI TREK.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American