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

Model Number	C2PIVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to shockwave via the post market empower cad clinical study.Two shockwave c2+ coronary intravascular lithotripsy (ivl) catheters were used to treat a lesion in the proximal left anterior descending artery (lad).A non-compliant balloon was used to pre-dilate the vessel.The first 2.5mm c2+ ivl catheter (reference mdr# 3015053858-2025-00029) was used which delivered 30 pulses at max inflation of 4atm before the balloon ruptured.A second 2.5mm c2+ ivl catheter (reference mdr# 3015053858-2025-00028) was used which successfully delivered 120 pulses at max inflation of 4atm with no alleged product malfunction.A drug eluting stent (des) was placed and multiple non-compliant balloons were used for post-stent dilation to complete the procedure.After the procedure, the patient experienced a non q-wave myocardial infarction (mi).This event was adjudicated by the clinical events committee (cec) which confirmed the periprocedural mi was attributable to the target vessel.The cec noted elevated ck-mb levels above ten times the upper limit within 48 hours of the procedure as well as side branch occlusion with no new q waves.It was determined that the mi was possibly related to the study device and definitely related to the procedure.There was no other patient sequalae reported.The patient was discharged five days after the index procedure.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the myocardial infarction could not be definitely determined based on the information available.The cec determined that the mi was possibly related to the study device and definitely related to the procedure.There is no indication that the balloon rupture of the first ivl catheter was 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.

• 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: 21417481
• Report Number: 3015053858-2025-00028
• Device Sequence Number: 12730517
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)250731(10)07A230720A
• 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): 02/19/2025

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: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 07A230720A
• 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: 01/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRUG ELUTING STENT - SYNERGY XD MONORAIL BOSTON SC.; NON-COMPLIANT BALLOON - SPRINTER LEGEND SC.; NON-COMPLIANT BALLOON - UNKNOWN MANUFACTURER (X3).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White