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

Model Number	3.5 X 12MM
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/09/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent a percutaneous coronary intervention (pci) procedure to treat a concentric de novo lesion located in the left circumflex (lcx) artery using a shockwave c2 plus coronary intravascular lithotripsy (ivl) catheter.Prior to the procedure, the target lesion was pre-dilated with a non-compliant (nc) balloon.When the ivl was advanced towards the target lesion, it was unable to cross so a stent was placed in the lcx and post dilated with a 3.5mm non-compliant (nc) balloon.The physician wanted more expansion so a 4.0mm nc balloon was used and immediately, a perforation was observed proximal to the lesion.The nc balloon was used to tamponade the vessel however, it was unsuccessful.The physician attempted to use a covered stent but couldn't go in due to the stent and severe angulation.The patient was transferred to surgery in an attempt to repair the aortic valve however, the patient expired.The physician believes that the cause of the patient's death was not due to the ivl.It was due to the patient's anatomy and vessel calcification along with the complications during surgical valve repair that ultimately contributed to the patient's death.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.For investigation therefore, a physical examination could not be performed.Based on the reported information, the ivl catheter was unable to cross the lesion and it was noted that a perforation occurred from proximal to lesion site.It is unknown if the perforation was treated but it was reported that the patient was transferred to surgery and subsequently expired.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.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): 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: 18223024
• Report Number: 3015053858-2023-00070
• Device Sequence Number: 14877319
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)250731(10)13A230718A
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 07/31/2025
• Device Model Number: 3.5 X 12MM
• Device Catalogue Number: C2IVL3512
• Device Lot Number: 13A230718A
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown