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

Model Number	C2IVL3512
Medical Device Problem Codes	Decrease in Pressure (1490); Difficult to Advance (2920)
Health Effect - Clinical Codes	Perforation (2001); Vascular Dissection (3160)
Date of Event	06/28/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device referenced in this report was discarded by the hospital after the procedure therefore, a physical examination could not be performed.Based on the provided information, the patient experienced a dissection prior to ivl usage.After ivl was performed, the patient was treated with rotablator, two stents were placed, and post dilatation was performed which is when perforation was observed.The timing of both the dissection and perf do not coincide the time ivl was used.Physician's perspective on what may have caused the event is unsure but felt that the calcium in the area treated with the ivl catheter was stalactite in composition.This created a loss in pressure in the ivl catheter, and then protruded through the vessel wall when post dilated with the 4.0 balloon.The patient expired at some point later in the day after the procedure.Shockwave medical is of the opinion that the observed adverse events (aes) do no coincide with the timing of ivl therapy and the relationship between the aes and ivl is unclear.Shockwave medical 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
A c2 ivl coronary catheter was used to treat a calcified coronary artery.During the procedure, the physician attempted to pass a 3.0 non compliant balloon(nc) prior to using shockwave ivl catheter, which wouldn't pass.Next, physician then used a 1.5 burr rota and then a 3.0 nc.It was then noted that a dissection flap occurred from the rotablator.Physician then placed a 5.5 guideliner and delivered a 3.5 c2 ivl catheter and treated a segment past where he used rota.It was noted that a loss of pressure occurred in the ivl catheter.Physician then placed a 3.25 x 38 and 3.25 x 15 xience and then passed ivus.After that, physician post dilated with a 3.5 x 25 nc and then a 4.0 x 20 nc.The perforation of vessel occurred after the 4.0x20 nc.Angiography after these steps showed perforation in the mid lad.Balloon went up and papyrus stent(s) were deployed.Physician's perspective on what may have caused the event is unsure but felt that the calcium in the area treated with the ivl catheter was stalactite in composition.This created a loss in pressure in the ivl catheter, and then protruded through the vessel wall when post dilated with the 4.0 balloon.It was reported that the patient was put in bypass and expired later that same day after the ivl procedure.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: NTRAVASCULAR 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
• MDR Report Key: 15085942
• Report Number: 3015053858-2022-00043
• Device Sequence Number: 4035145
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)230930(10)A210913B
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: 09/30/2023
• Device Model Number: C2IVL3512
• Device Catalogue Number: C2IVL3512
• Device Lot Number: A210913B
• 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: 06/29/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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: 6FR EBU GUIDE; IVUS PHILLIPS; PROWATER AND ROTA WIRES; TREK NC ABBOTT BALLOONS; XIENCE AND PAPYRUS COVERED STENTS
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 50 KG