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

Model Number	C2PIVL3512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Myocardial Infarction (1969); Obstruction/Occlusion (2422)
Date of Event	04/16/2024
Type of Reportable Event	Death
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 the myocardial infarction could not be definitively determined based on the information available.There was no ivl malfunction reported.The cec determined that the mi is possibly related to the study device and definitely related to the procedure.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.
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 a lesion in the mid left anterior descending (lad) artery.The ivl catheter successfully delivered 120 pulses at 6 atm max.There was no report of an ivl device malfunction.A month after the index procedure, the patient experienced non-cardiac chest pain.The chest pain was resolved, and the patient was discharged the next day.The clinical site had determined that the relationship of the chest pain and to the procedure is not related to the ivl device.Additionally, the patient's bloodwork indicated that ckmb and troponin levels were outside the normal range the day of the index procedure.The site indicated that bloodwork levels could fluctuate between pre-visit and post-visit.The subject was instructed to continue taking medications and no new medications were added.The clinical site had determined that the relationship of this event and to the procedure is not related to the ivl device.This event was sent to the clinical events committee (cec) for adjudication of the patient's myocardial infarction (mi).The film was reviewed, and they observed a side branch occlusion.The ecg was completed, and the mi was categorized as a non-st-elevation myocardial infarction (nstemi).The cec determined that the mi is possibly related to the study device and definitely related to the procedure.
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 the myocardial infarction, cardiac arrest, and death could not be definitively determined based on the information available.There was no ivl malfunction reported.The cec determined that the mi is possibly related to the study device and definitely related to the procedure.The clinical site determined that that death and cardiac arrest was possibly related to the study device and procedure.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.
Event or Problem Description
Shockwave medical received additional information from the clinical site.Months after the index procedure, the patient expired due to cardiorespiratory arrest.The site determined that the death was possible to the study device and procedure.The patient had agonal breathing and could not get a blood pressure.Additionally, the patient was not responding well to advanced cardiac life support (acls).

• 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: 20739542
• Report Number: 3015053858-2024-00128
• Device Sequence Number: 8483934
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)251231(10)02A231218A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 12/31/2025
• Device Model Number: C2PIVL3512
• Device Catalogue Number: C2PIVL3512
• Device Lot Number: 02A231218A
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: POST-DILATATION CATHETER- ABBOTT; POST-DILATATION CATHETER- ABBOTT; PRE-DILATATION CATHETER - ABBOTT; PRE-DILATATION CATHETER - ABBOTT
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 69 YR
• Patient Sex: Female