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

Model Number	C2PIVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was discarded and will not be returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.Based on the information provided, the cause of the mi could not be definitively determined; however, based on the information provided, the ivl catheter successfully delivered 60 pulses at 10 atm, which is considered off-label use per the following indications in the instructions for use: "balloon compliance chart referenced in shockwave c2+ coronary intravascular lithotripsy (ivl) catheter instructions for use, 10 atm is (related burst pressure) of the balloon." there was no ivl 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.Complaints will continue to be monitored for trending purposes.
Event or Problem Description
This event was reported to shockwave via the post market empower cad clinical study.On july 12, 2024, a shockwave c2+ intravascular lithotripsy (ivl) catheter was used to treat a lesion in the left mid anterior descending (lad) artery.The ivl catheter successfully delivered 60 pulses at 10 atm.Post dilation was performed, and three (3) stents were successfully placed.There was no report of an ivl device malfunction.Myocardial infarction (mi) occurred the same day as the index procedure.The patient complained of worsening hypertension, chest pain, back pain, mild nausea and vomiting.The symptoms were treated with hydralazine, zofran and morphine intravenously with favorable effects to the patient.In addition, the patient was treated with aspirin and prasugrel.An ekg was obtained, and the patient was released the following day.The clinical site has determined that the relationship of mi to the study and procedure was possible/definite.

• 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: 20539818
• Report Number: 3015053858-2024-00123
• Device Sequence Number: 6641469
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)250930(10)14A230922A
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 10/25/2024

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: 09/30/2025
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 14A230922A
• 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: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2023
• 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: MEDTRONIC - BALLOON; MEDTRONIC - ONYX FRONTIER DRUG ELUTING STENT; MEDTRONIC - ONYX FRONTIER DRUG ELUTING STENT; MEDTRONIC - ONYX FRONTIER DRUG ELUTING STENT
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female