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

Model Number	C2IVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Ventricular Fibrillation (2130)
Date of Event	09/22/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical inc.For investigation therefore, no investigation can be performed.Based on the reported event, the patient was already having chest pain and was in complete heart block (chb) when she presented to the emergency room and then to the cath lab.The patient was given atropine upon arrival at the hospital.During the ivl treatment, the patient experienced ventricular fibrillation (vfib).The patient was provided shock and sinus rhythm returned to normal.Prior to the patient being off the table, the patient coded multiple times.An impella was inserted and subsequently, the ivl treatment was ultimately successful.The patient was transferred to the icu but expired later that evening.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.
Event or Problem Description
It was reported that a patient presented to the emergency room with chest pain and was in complete heart block (chb).The patient was given atropine upon arrival at the hospital.The patient was transferred to the cath lab with normal sinus rhythm with stable vital signs and then underwent a percutaneous coronary intervention (pci) procedure.The physician identified a blockage in the right coronary artery (rca) and predilated it with a non-complaint (nc) balloon, however the physician was unable to pass a stent.The physician requested a shockwave c2 coronary intravascular lithotripsy (ivl) catheter.Accordingly, the balloon delivered several cycles, however during the last cycle of pulses, the patient went into ventricular fibrillation (vfib).The patient was shocked with a defibrillator and heartbeat returned to normal sinus rhythm.At that point, the calcium had been modified enough by the ivl and a stent was able to be advanced to the lesion and was subsequently deployed.After post dilatation of the stent, the procedure was ultimately completed.The patient was transferred off the table however, the patient coded again before leaving the cath lab.The patient was shocked once again and returned to the table.The physician determined that the posterior descending artery (pda) branch off the rca was stumped off.Furthermore, the patient was reported to have coded several more times while the physician attempted to reopen the pda branch.The procedure was ultimately successful and an impella was placed to allow for hemodynamic stability and a temporary pacemaker was also inserted.The patient was transferred to the intensive care unit (icu) from the cath lab, but the patient expired later that evening.
Additional Manufacturer Narrative
See correction to d4: udi.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• 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: 17876611
• Report Number: 3015053858-2023-00060
• Device Sequence Number: 17243647
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(01)A230113D
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/23/2025

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: 01/31/2025
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A230113D
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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: ATROPINE - ENTOD PHARMACEUTICALS LTD.; DEFIBRILLATOR - UNKNOWN MANUFACTURER; IMPELLA PERCUTANEOUS VENTRICULAR ASSIST DEVICE; NON-COMPLIANT BALLOONS - UNKNOWN MANUFACTURER; PACEMAKER - UNKNOWN MANUFACTURER; STENT - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White