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

Model Number	C2IVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a percutaneous coronary intervention (pci) procedure to treat a concentric de novo lesion located in the left anterior descending artery (lad).Access to the lesion was obtained via the radial artery.A shockwave c2 coronary lithotripsy (ivl) catheter was used to treat the target lesion.The physician intended to treat the proximal lad but decided to treat the distal lesion first.After the ivl balloon delivered 60 pulses, a vessel perforation occurred in the lad.The physician placed a coronary balloon to manage the perforation while a graftmaster¿ rx coronary stent graft system was prepared.The graftmaster was unable to treat the perforation.The patient's condition declined.The patient's blood pressure dropped, electrocardiogram (ekg) changed, and the physician had to perform pericardiocentesis due to pericardial effusion and then transferred the patient to surgery for a successful bypass.Since the patient was also on schedule for a transcatheter aortic valve replacement (tavr), the surgeon also ended up replacing the aortic valve and treating the perforation with one surgical procedure.The patient was extubated on (b)(6) 2023 and is currently an in-patient at a rehab facility and is doing well.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.For investigation therefore, a physical examination could not be performed.Based on the reported event, the patient experienced perforation after ivl balloon successfully delivered 60 pulses to the target vessel.The physician attempted to treat the perforation with a graftmaster covered stent, however, it was unsuccessful.The patient's condition started to decline so the patient was transferred to surgery and had undergone a successful coronary artery bypass.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95133
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054 ; 8777754846
• MDR Report Key: 17302478
• Report Number: 3015053858-2023-00045
• Device Sequence Number: 3827352
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)241130(10)A221118D
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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: 11/30/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A221118D
• 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: 06/19/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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: GRAFTMASTER¿ COVERED STENT - ABBOTT VASCULAR
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White