MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

Model Number	C2PIVL2512
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.Balloon ruptures are a known failure mode with a low probability of occurrence.Contributing factors include patient calcium, damage caused when the balloon wall comes into close contact with the device emitters, likely causes include (a) an irregular calcium lesion capable of compressing the balloon wall into close proximity with the emitter(s) and/or (b) an incompletely inflated balloon.The shockwave intravascular lithotripsy (ivl) system with the shockwave c2+ coronary ivl catheter generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure not to exceed 4 atm during ivl treatment, and 6 atm for post dilatation.The pressure used for the ivl balloon catheter is much lower than other balloon catheters used in percutaneous coronary intervention (pci), thus the risk associated with loss of balloon pressure during ivl catheter use is negligible.The associated patient risk for this failure mode is low and adequately captured in swmi's risk documentation.The cause of the myocardial infarction could not be definitively determined based on the information available.The cec determined that the relationship to the study device is possible, and the relationship to the study procedure is definitely related.Swmi medical safety assessed the event as possibly related to the study device and causal to the study procedure.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 pre-market forward cad ide clinical study.Three shockwave c2+ coronary intravascular lithotripsy (ivl) catheters and one shockwave javelin pre-market coronary ivl catheter were used to treat a severe calcified lesion in the left anterior descending artery (lad).This report pertains to the first c2+ catheter.Refer to (b)(6) (mdr# 3015053858-2025-00125) for the second c2+ catheter and (b)(6) (mdr #3015053858-2025-00126) for the third c2+ catheter.For the first c2+ catheter, 90 ivl pulses were successfully delivered at 4 atm before a balloon rupture occurred.A second c2+ catheter was used to deliver 120 ivl pulses at 4 atm.For the third c2+ catheter, 120 ivl pulses were successfully delivered at 4 atm.The last catheter used to treat the lesion was the pre-market javelin coronary ivl catheter which successfully delivered 120 pulses.There was no ivl malfunction reported for any of the other catheters used.A dissection was noted after the use of the second c2+ ivl catheter and was treated successfully by stenting.The clinical site determined that the dissection was not related to the ivl device and definite to the procedure.After the dissection was stented, a diagonal branch was jailed.The physician unsuccessfully attempted to rescue the jailed branch at the end of the procedure, right before using ivus.The clinical site determined that this event was not related to the ivl device and definite to the procedure.Hypotension was noted post procedure.The subject stayed overnight for observation with no intervention nor medication administered to treat the hypotension which was resolved the following day.The patient was then discharged a day after the index procedure.The clinical site determined that the hypotension was not related to the ivl device nor the procedure.At discharge, the subject's ckmb levels were 24.4 which was just over 3 times the normal limit.The clinical site determined that this event was not related to the ivl device and possible to the procedure.This event was sent to the clinical events committee (cec) for adjudication of the myocardial infarction (mi).The cec determined that the mi was a non q-wave mi attributable to the target vessel.They determined that the mi was possibly related to the study device and definitely related to the procedure.The film was reviewed, and they observed a side branch occlusion of the diagonal artery.

• 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: 23469446
• Report Number: 3015053858-2025-00124
• Device Sequence Number: 12963502
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)261031(10)19A241012B
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 19A241012B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2024
• 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: 2.50 X 38 - SYNERGY DES - BOSTON SCIENTIFIC; 2.50 X 38 - XIENCE SKYPOINT DES - ABBOTT
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White