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	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Pericardial Effusion (3271)
Date of Event	06/23/2023
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 3-vessel disease.The patient had an rca (right coronary artery), cfx (circumflex coronary artery), and lad (left anterior descending artery) diseased vessels.A shockwave c2 coronary lithotripsy (iv) catheter was only used in the lad and was treated last.Following a successful ivl treatment, the physician used a 3.0mm non-compliant (nc) balloon for post dilatation.The nc balloon ruptured so another nc balloon was used.However, extravasation was observed outside of the target vessel due to a perforation in the artery.The physician used covered stents to close the perforation.It was reported that the patient's condition started to decline so extracorporeal membrane oxygenation (ecmo), which is a form of life support, was provided.Pericardiocentesis was also performed to remove fluid from the pericardial sac.The patient was then taken to the operating room (or) because blood was still coming from the heart drain and not from the lad.This was confirmed via angiography imaging.The patient is still in the hospital but now off ecmo.The patient is reported to be neurologically alert.
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 extravasation outside of the target vessel due to perforation in the artery.The perforation was treated with a covered stent, however, the patient's condition started to decline.The patient was provided extracorporeal membrane oxygenation (ecmo), which is a form of life support and pericardiocentesis was also performed to remove blood from the pericardial sac.The physician did not attribute the perforation to the ivl but believes that the perforation occurred when the non-compliant (nc) balloon ruptured.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 release 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 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054 ; 8777754846
• MDR Report Key: 17221830
• Report Number: 3015053858-2023-00041
• Device Sequence Number: 12535410
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)240630(10)A220610H
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/23/2023

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: 06/30/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A220610H
• 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: 06/23/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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: COVERED STENTS - UNKNOWN BRAND OR MANUFACTURER; NON-COMPLIANT (NC) CATHETERS - UNK BRAND OR MNFR
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White