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

Model Number	C2PIVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Perforation of Vessels (2135)
Date of Event	01/31/2025
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 root cause of chest pain and perforation 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
A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the mid-left anterior descending (mlad) arteries which demonstrated an fractional flow reserve (ffr) of 0.76.The patient presented with chest pain.Initial angiograms showed mild disease in the right and left coronary arteries.The target lesion was pre-dilated with a 2.50x15mm nc euphoria balloon at 14 atm.A 3.00x12mm ivl catheter was used, delivering 80 pulses at 4 atm.The lesion yielded after the final pulses, but a large perforation in the mlad was noted.The ivl balloon was temporarily inflated proximal to the perforation to slow the extravasation of blood into the pericardial space.Two synergy drug eluting stents were placed to seal off the perforation but subsequent angiogram showed it was still occurring, so the physician placed two papyrus covered stents to further seal it off.Post-stent dilatation was completed, followed by emergent echocardiogram and placement of a peri-cardiocentesis drain.The patient remained stable and left the catheterization lab shortly afterwards.Approximately one hour later, the patient experienced additional chest pain and was returned to the cardiac catheterization lab for evaluation.An angiogram showed active perforation, leading to emergent single vessel bypass (cabg) of the lad.The surgery was successful, and the patient was stable post-operation.The patient's medical history includes chest pain leading to hospitalization for heart catheterization and percutaneous coronary intervention (pci).The physician speculated a potential connective tissue disorder (ehlers-danlos syndrome) as a contributing factor.

• 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 95054
• Manufacturer (Section G): SHOCKWAVE MEDICAL, INC; 5403 besty ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara 95054
• MDR Report Key: 21513229
• Report Number: 3015053858-2025-00044
• Device Sequence Number: 15447300
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)260831(10)05A240801B
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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: 08/31/2026
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 05A240801B
• 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: 02/03/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: BALLOON - NC EUPHORIA.; COVERED STENTS - PAPYRUS(2X).; DRUG ELLUTING STENTS - SYNERGY (2X).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Male