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

Model Number	C2IVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Hematoma (1884); Thrombosis/Thrombus (4440)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to shockwave medical, inc.For investigation therefore, a physical investigation of the device could not be performed.The cause of the thrombus that occurred post ivl treatment could not be definitively determined.There was no ivl device malfunction reported.Following clinical events committee (cec) adjudication of this event, it was noted that the thrombus in the lesion was due to retrograde extension of hematoma from the cfx (target lesion) probably related to the device and definitely related to the procedure.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.
Event or Problem Description
A shockwave c2 coronary intravascular lithotripsy (ivl) catheter was used during a percutaneous coronary intervention (pci) procedure to treat a lesion located in the left circumflex (cfx).Peri-procedure, the patient was provided 7000 units of heparin.The ivl balloon successfully delivered 30 pulses with no malfunction of the device reported.Twenty-three minutes (23) after the completion of the index procedure, the patient reported chest pain.The patient was sent back for imaging and a coronary thrombus was noted in the non-target lesion.The patient underwent a second pci (revascularization) on the same day.During a second pci revascularization procedure, there was bleeding in the left groin and patient's systolic blood pressure (sbp) was at 80mmhg.The patient was provided atropine delivered intravenously (iv), given reglan for nausea, norepinephrine infusion, and one unit of packed red blood cells (prbc).Then an ultrasound was performed, and the patient was negative for pseudoaneurysm.After monitoring, the patient was subsequently discharged to home.Following clinical events committee (cec) adjudication of this event, it was noted that the thrombus in the lesion was due to retrograde extension of hematoma from the cfx (target lesion) probably related to the device and definitely related to the procedure.

• 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 (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 ; 8777754846
• MDR Report Key: 18924408
• Report Number: 3015053858-2024-00023
• Device Sequence Number: 11874550
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)241130(10)A221109C
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

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: 11/30/2024
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: A221109C
• 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: 03/05/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NC TREK CORONARY DILATATION CATHETER - ABBOT CARDI; XIENCE SKYPOINT¿ DRUG-ELUTING STENT (DES) ABBOTT
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White