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

Model Number	C2PIVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to shockwave via the post market empower cad clinical study.A shockwave c2+ intravascular lithotripsy (ivl) catheter was used to treat two lesions in the proximal left anterior descending (lad) artery.Lesion one was treated and the ivl catheter delivered 30 pulses at 6 atmospheric pressures (atm).One stent was successfully placed.Lesion two was treated with 40 pulses at 6 atmospheric pressures (atm).Two stents were successfully delivered.Myocardial infarction (mi) occurred along with chest pain on (b)(6) 2024, one day after the ivl treatment, prior to discharge.A review of the angiogram revealed a side branch loss during percutaneous coronary intervention (pci).The patient was treated with ticagrelor and aspirin.After stabilization, an ekg (electrocardiogram) was performed, showing no abnormalities and stable vitals.The patient was discharged the following day, (b)(6) 2024.The clinical site has determined that the relationship of the mi and chest pain to both the study and procedure was probable/definite.
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 mi and chest pain could not be definitively determined based on the information available.No ivl malfunction was 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 before 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: 20525652
• Report Number: 3015053858-2024-00122
• Device Sequence Number: 7920438
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)251031(10)01A231031A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: 10/31/2025
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 01A231031A
• 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: 09/26/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• 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: ABBOTT - XIENCE DRUG ELUTING STENT; ABBOTT - XIENCE DRUG ELUTING STENT; ABBOTT - XIENCE DRUG ELUTING STENT; EUPHORA - BALLOON; NC SAPPHIRE - BALLOON
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female