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 Codes	Cardiac Arrest (1762); Chest Pain (1776); Ischemia (1942); Myocardial Infarction (1969); Respiratory Failure (2484); Thrombosis/Thrombus (4440)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
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 cardiac arrest, thrombus, chest pain, and acute respiratory failure could not be definitively determined based on the information available.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.
Event or Problem Description
This event was reported to shockwave via the post market empower cad clinical study.A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the left anterior descending (lad) arteries.110 pulses were successfully delivered and there was no report of any ivl device malfunction.Cardiac arrest occurred an hour after the index procedure.The patient received cardiopulmonary resuscitation (cpr) and defibrillation.The patient returned to the catheterization lab (cath lab) where the previous stent had thrombosed and required ballooning.After the cardiac arrest, the patient had musculoskeletal chest pain and acute respiratory failure which required 2l nasal cannula.The patient stayed in the hospital for 4 days and subsequently was discharged home with no residual issues.The clinical site has determined a possible relationship between the cardiac arrest and the ivl device.
Event or Problem Description
This event was sent to the clinical events committee (cec) for adjudication of the patient's cardiac arrest, revascularization, and stent thrombosis.It was reported that cardiac arrest occurred post index procedure.The cec determined that the cardiac arrest is possibly related to the study device and definitely related to the procedure.Additionally, it was reported that the patient had recurring ischemia post index procedure and the cath revealed thrombus at the stent site requiring repeat intervention (pci).There were objective signs of ischemia at rest (ecg changes) or during the exercise test (or equivalent), presumably related to the target vessel.The cec determined that the stent thrombosis and revascularization are 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 cardiac arrest, thrombus, ischemia, chest pain, and acute respiratory failure could not be definitively determined based on the information available.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.
Event or Problem Description
This event was sent to the clinical events committee (cec) for adjudication of the patient's myocardial infarction (mi).The cec determined that the mi was a non q-wave mi attributable to the target vessel.They determined that the mi was possibly related to the study device and definitely related to the procedure.Creatine kinase-mb levels were greater than 5 but less than 10 upper limit of normal (uln).There was no q wave.
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 cardiac arrest, thrombus, ischemia, myocardial infarction, chest pain, and acute respiratory failure could not be definitively determined based on the information available.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.

• 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: 20218531
• Report Number: 3015053858-2024-00103
• Device Sequence Number: 20769897
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)251031(10)06A231019A
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,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: 10/31/2025
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 06A231019A
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 01/21/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/19/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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-STENT DILATATION CATHETER -UNKNOWN MFGR; POST-STENT DILATATION CATHETER -UNKNOWN MFGR; SYNERGY DRUG ELUTING STENT - BOSTON SCIENTIFIC
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Female