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

Model Number	C2PIVL2512
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure, catheter error: end of failure (eol), could not be replicated.Testing of the device demonstrated that the catheter successfully delivered 100 pulses without any error messages.The cause of the myocardial infarction one day post-op could not be definitively determined with the information available.There is no indication that the eol error is related to the patient outcome.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 left anterior descending artery (lad).Multiple non-shockwave balloons were used to pre-dilate the vessel.After 70 ivl pulses were delivered at a max of 6 atm, the pulsing stopped and a catheter error: end of life (eol) appeared.The procedure was completed without the use of a second catheter.Two des stents were placed in the lad followed by post-dilatation with multiple non-shockwave balloon catheters.There was no patient sequalae reported.The patient was discharged a day after the index procedure.One day post-op, the patient experienced a non-q-wave myocardial infarction (mi).This event was adjudicated by the clinical events committee (cec) which confirmed the mi was attributable to the target vessel.The mi was reported to occur a day after the index procedure.The cec noted loss of a side branch and no new q waves.The patient's creatine kinase-mb (ck-mb) levels were greater than 5 times the upper limit of normal (uln), but less than 10 times the uln.It was determined that the mi 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: 21403056
• Report Number: 3015053838-2025-00022
• Device Sequence Number: 18478046
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)260228(10)01A240220A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/18/2025

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 Expiration Date: 02/28/2026
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 01A240220A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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: NC SPRINTER POST-DIL. CATH. - 3.0 X 21 - MEDTRONIC; ONYX FRONTIER DES- 2.75 X 38 - MEDTRONIC; ONYX FRONTIER DES- 3.50 X 34 - MEDTRONIC; POST-STENT DILATATION 1.50 X 15 CATHETER - UNKNOWN; POST-STENT DILATATION 2.5 X 15 CATHETER - UNKNOWN; POST-STENT DILATATION 2.50 X 20 CATHETER - UNKNOWN; POST-STENT DILATATION 3.0 X 20 CATHETER - UNKNOWN; POST-STENT DILATATION 3.50 X 9 CATHETER - UNKNOWN; TAKERU POST-DILATATION CATHETER 5.50 X 21 - TERUMO; TAKERU PRE-DILATATION CATHETER - 2.50 X 2 - TERUMO; TAKERU PRE-DILATATION CATHETER 2.50 X 15 - TERUMO
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White