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

Model Number	C2PIVL3012
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Chest Pain (1776); Reduced Blood Flow (4598)
Date of Event	02/05/2025
Type of Reportable Event	Death
Event or Problem Description
A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a denovo lesion with nodular calcium in the left anterior descending artery (lad).After 40 pulses were delivered, the balloon lost pressure.Post ivl, a cutting/scoring balloon was used followed by the placement of a drug eluting stent (des).The procedure was finished successfully, and the drug eluting stents were implanted as intended.The patient, who had triple vessel disease and diabetes, passed away post-procedure.It was reported that the patient may have lost septal flow, which was supporting the right coronary artery (rca).The physician performed a percutaneous coronary intervention (pci) before the patient expired.The patient did not pass away immediately after the ivl treatment and showed only slight chest pain when the septal flow decreased.The patient expired during recovery.The access site was femoral and the interval between the ivl treatment and the patient's death is unknown.The cause of the death is unknown.It was reported that the patient had multiple co-morbidities and the death was not related to the pci 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 cause of the reduced blood flow, chest pain, and subsequent death could not be definitively determined based on the information available.The interval between the ivl treatment and the patient's death is unknown.The procedure was finished successfully, and the drug eluting stents were implanted as intended.The cause of the death is unknown.It was reported that the patient had multiple co-morbidities and the death was not related to the pci 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 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: 21518564
• Report Number: 3015053838-2025-00045
• Device Sequence Number: 12875542
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)260831(10)01A240829B
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 01A240829B
• 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: 02/05/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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: CUTTING/SCORING BALLOON - UNKNOWN MANUFACTURER.; XIENCE DRUG-ELUTING STENT (DES) - ABBOTT.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown