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

Model Number	C2IVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/25/2024
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 perforation could not be definitively determined based on the information available.The physician stated that ivl could be an indirect cause of the vessel perforation, but it is unknown and unlikely.The physician also stated that the post-dilation of stent with a 4.5mm nc balloon is likely the direct cause of the vessel perforation.There was no ivl device 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.
Event or Problem Description
Two shockwave c2 coronary intravascular lithotripsy (ivl) catheters were used to treat a lesion in the coronary arteries.This report is for the first catheter used in the procedure.Refer to mdr# 3015053858-2024-00131 for the second catheter.Both catheters successfully delivered 80 pulses at 4 atm.During the delivery of the ivl catheter to the lesion, no issues were observed at the treatment site, but hematoma was observed at a distant site.A 3.0mm xience stent was implanted following ivl treatment.Upon post-dilation of the stent using a 4.5mm nc balloon, a vessel rupture occurred.The physician stated that the vessel was highly calcified, and the diameter of the nc balloon was too large.Hemostasis was attempted with a ryusei balloon catheter and covered stent but was unsuccessful, so the patient was transferred to surgery.A coronary artery bypass graft (cabg) was performed alongside an aortic stenosis (as) and aorta ascendens (aa) replacement operation.The surgery was completed with no issues and the patient is currently stable and hospitalized in the icu.The physician stated that ivl could be an indirect cause of the vessel perforation, but it is unknown and unlikely.The physician also stated that the post-dilation of stent is likely the direct cause of the vessel perforation.

• 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: 20776506
• Report Number: 3015053858-2024-00130
• Device Sequence Number: 8044906
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)260131(10)04A240131A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: 01/31/2026
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: 04A240131A
• 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: 10/28/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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: 6 FR GUIDEPLUS GUIDE CATHETER; NC KAMUI 4.5 X 15 - POST-DILATATION BALLOON; PK PAPYRUS 3.0 X 20 STENT; RYUSEI 4.0 X 20 BALLOON; XIENCE SKYPOINT 3.0 X 48 STENT; XIENCE SKYPOINT 3.5 X 38 STENT
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male