MAUDE Adverse Event Report: Shockwave Medical, Inc. Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter

Model Number	C2PIVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/26/2026
Type of Reportable Event	Death
Event or Problem Description
A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the right coronary artery (rca).It was reported that a patient presented emergently with a st-elevation myocardial infarction (stemi) and was clinically unstable prior to shockwave ivl treatment.Multiple inflations with non-ivl balloons were performed before the shockwave ivl device was used.The ivl device was successfully prepared, and all 120 pulses were delivered.Post ivl treatment, a grade 3 vessel perforation was identified in the distal rca.The patient required urgent unplanned interventions, including pericardiocentesis and cardiopulmonary resuscitation (cpr).The procedure was completed by placement of two papyrus covered stents and ptap was performed.Pre-dilation had been performed with a 2.0 mm takeru balloon at 12 atm and a 2.5 mm nc euphora balloon at 20 atm, followed by post-dilation with a 3.0 x 15 mm nc euphora balloon.The procedure was completed using covered stents instead of the originally planned drug-eluting stents (des) due to the perforation.The patient remained stable during the immediate procedure, but they subsequently died on 29aug2026 after being placed on comfort care.There was no reported device malfunction.The physician attributed the perforation to the patient's severe calcification and the presence of prior stents in the rca.Ivl was applied distal to the existing stents.The site stated that the perforation was not believed to be related to a problem with the shockwave balloon.
Additional Manufacturer Narrative
The device referenced in this report was discarded and not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the reported perforation and subsequent patient death could not be definitively determined based on the information available.There was no reported device malfunction.The physician attributed the perforation to the patient's severe calcification and the presence of prior stents in the rca.Ivl was applied distal to the existing stents.The site stated that the perforation was not believed to be related to a problem with the shockwave balloon.Per shockwave medical safety, the event was assessed as possibly related to the shockwave device and a causal relationship to the procedure.It is impossible to determine the relatedness of the use of ivl in the setting of active cpr, use of co-contaminate devices, stenting, ballooning, and heavy calcification.It remains possible that the ivl device contributed and is conservatively assessed as possibly related.The perforation occurred during the procedure and is procedure related.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 IVL System with the Shockwave C2+ Coronary IVL Catheter
• Common Device Name: Shockwave IVL System with the Shockwave C2+ Coronary 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: 50725390
• Report Number: 3015053858-2026-00119
• Device Sequence Number: 21479379
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• UDI-Public: (01)00195451000607(17)280430(10)02A260524B
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/10/2026

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 Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 02A260524B
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2026
• 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: 2.0 mm Takeru balloon - Terumo Interventional Sys; 2.5 mm NC Euphora - Medtronic; 2x Papyrus covered stents - Biotronik; 3.0 x 15 mm NC Euphora - Medtronic
• Outcome Attributed to Adverse Event: Required Intervention; Death; Other; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female