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	Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/11/2024
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 perforation, hypotension, atrial fibrillation, pericardial tamponade, and myocardial infarction could not be definitively determined based on the information available.It was reported that the perforation occurred upon post-dilatation of the stent placed post ivl treatment.Furthermore, it was reported that the atrial fibrillation was likely due to perforation and bleeding into the pericardial space.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 distal left circumflex arteries.10 pulses were successfully delivered at 4 atm.There was no ivl malfunction reported.This event was sent to the clinical events committee (cec) for adjudication of the perforation, hypotension, atrial fibrillation, pericardial tamponade, and myocardial infarction.The cec determined that the myocardial infarction (mi) occurred within 48 hours post-procedure, and was a non q-wave mi attributable to the target vessel and determined to be possibly related to the study device and definitely related to the procedure.The troponin levels were greater than 70 x uln within 48 hours of the index procedure.The cec determined that pericardial tamponade and hypotension were also possible to the study device and definitely related to the procedure.During post-stent ballooning, perforation was reported and managed with 2 covered stents.The post coronary perforation was managed with a placement of pericardial drain.The cec stated that the atrial fibrillation that occurred after was likely due to perforation and bleeding into the pericardial space.They also determined that the atrial fibrillation was possibly related to the study device and definitely related to the procedure.

• 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: 21139892
• Report Number: 3015053858-2025-00005
• Device Sequence Number: 6957427
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)251231(10)06A231212A
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/13/2025

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: 06A231212A
• 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: 12/19/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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: PAPYRUS 3.50 X 15 -COVERED STENT - BIOTRONIK; PAPYRUS 3.50 X 15 -COVERED STENT - BIOTRONIK; POST-DILATATION CATHETER - 3.50 X 15 - UNKNOWN MFG; POST-DILATATION CATHETER - 4.50 X 15 - UNKNOWN MFG; POST-DILATATION CATHETER - 4.50 X 15 - UNKNOWN MFG; POST-DILATATION CATHETER -4.00 X 15 - UNKNOWN MFG; POST-DILATATION CATHETER-3.50 X 8.0 - UNKNOWN MFG; PRE-DILATATION CATHETER - 2.50 X 12 - ABBOTT; XIENCE SKYPOINT 3.25 X 28 - DRUG-ELUTING STENT
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female