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	Angina (1710); Chest Pain (1776); Myocardial Infarction (1969)
Date of Event	05/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two shockwave c2ivl coronary lithotripsy (ivl) catheters were used on this patient.Reportedly, post index percutaneous coronary intervention (pci) procedure for the post market empower cad clinical study, patient # 112, 001 was reported to have experienced 9/10 chest pain radiating to the right jaw.Cardiac angiogram showed st depressions and the patient was given nitroglycerin but without relief.Intravenous trindil drip was started and when the patient was brought back to the cath lab, there was a lab dissection observed.The physician treated the dissection with rx stents x 4.The patient was transferred to the cardiothoracic intensive care unit (cticu).Two days later, the patient was reported to have a heart failure reduced ejection fraction (ef).It was reported to have been treated with medication.Echocardiogram post pci ef was 40% (baseline was 64%), heart failure consulted.The patient was warm and well perfused, but volume was overloaded.Patient was advised to continue cardiac medication (hydralazine) to allow for increase fluid removal.The patient's ef was also associated with orthopnea (sensation of breathlessness).
Additional Manufacturer Narrative
The devices referenced in this report were not returned to shockwave medical, inc.After the procedure therefore, a physical investigation could not be performed.Based on the limited provided information, post index percutaneous coronary intervention (pci) procedure, the patient experienced angina and later found a dissection.The dissection was treated with stent implantation.Two days later, the patient was reported to have a heart failure reduced ejection fraction (ef).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.2nd device used during the index procedure: cp-11327 lot number: a220915d expiration date: 09/30/2024 manufacturng date: 09/15/2022.
Event or Problem Description
Additional information received on 05mar2024: a cec adjudication hearing was conducted and it was determined that the reported adverse event, unstable angina, was adjudicated as myocardial infarction (mi).The mi has been cec adjudicated to be possibly related to the study device.
Additional Manufacturer Narrative
Additional information received on 05mar2024: a cec adjudication hearing was conducted and it was determined that the reported adverse event, unstable angina, was adjudicated as myocardial infarction (mi).The mi has been cec adjudicated to be possibly related to the study device.The adverse event occurred at the time of the index procedure.The cause of the myocardial infarction could not be determined with the available information and there was no malfunction reported for the c2 ivl catheters that were used.

• 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: 17195184
• Report Number: 3015053858-2023-00037
• Device Sequence Number: 5806763
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)240930(10)A220915D
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: 09/30/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A220915D
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 03/05/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American