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	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to shockwave via the post market empower cad clinical study.A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the obtuse marginal artery branch of the proximal left circumflex coronary artery (lcx).Multiple scoring/cutting balloons were used for pre-dilatation, post-dilatation, and post-stent dilatation of the vessel.The 2.5 mm c2+ ivl catheter was used to deliver 120 pulses at max inflation of 6atm with no alleged product malfunction.A drug eluting stent (des) was placed to complete the procedure.The day 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 reviewed the film and noted loss of side branch.It was determined that the mi was possibly related to the study device and definitely related to the procedure.There was no other patient sequelae reported.The patient was discharged one day after the index procedure.Approximately 3 weeks post-procedure, the patient presented to the emergency department with non-cardiac chest pain.The patient had mildly elevated troponin levels and was given iv bolus.Electrocardiogram showed no ischemic changes.This event was classified as a spontaneous non-q-wave myocardial infarction but it was undetermined if the mi was attributable to the target vessel.The cardiologist recommended medical management and optimization of medication.The patient was discharged two days later.The site determined that this event was not related to the study device and possibly related to the 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 two myocardial infarction events could not be definitely determined based on the information available.The cec determined that the first mi was possibly related to the study device and definitely related to the procedure and that the second mi was not related to the study device and possibly related to the procedure.There was no allegation of ivl catheter malfunction.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: 21470976
• Report Number: 3015053838-2025-00038
• Device Sequence Number: 3652545
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)251031(10)02A231018A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/26/2025

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: 10/31/2025
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 02A231018A
• 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: 01/28/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRUG ELUTING STENT: MEDTRONIC ONYX FRONTIER RX; SCORING/CUTTING BALLOON: ABBOTT; SCORING/CUTTING BALLOON: BSCI NC EMERGE MR; SCORING/CUTTING BALLOON: BSCI NC EMERGE MR; SCORING/CUTTING BALLOON: UNKNOWN MANUFACTURER; SCORING/CUTTING BALLOON: UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White