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

Model Number	C2IVL3012
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	08/26/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The complaint device was not returned by the reporting party.Therefore, inspection of the device could not be performed.However, this event is being acknowledged to be used for trending purposes.The root cause for the difficulties to cross is likely related to the intended treatment of an in-stent restenosis in which the device had difficulties to cross, which is outside the indications for use for the c2 ivl device.Furthermore, the ivl device was incorrectly prepped prior to use; the catheter was tracked through a stent to a stented lesion, and the device was taken out and then reintroduced into the sheath.The loss of balloon wrap profile after inadvertently expanding the balloon during prep and after pulsing the device, and presence of the stents could have possibly contributed to the inability to advance/cross.The root cause for the myocardial infarction and subsequent death of the patient could not be definitively determined.Based on the physician's opinion, the physician reported that the patient had st elevations prior to ivl treatment, and minimal working vessels, and the right coronary artery (rca) was completely occluded.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
A shockwave c2 coronary intravascular lithotripsy (ivl) device was used to treat an in-stent stenosis, which is off-label per the device instructions for use; however, the physician elected to proceed with the ivl procedure.The physician reported that the patient had st elevations prior to ivl treatment, and minimal working vessels, and the right coronary artery (rca) was completely occluded.During preparation of the ivl device, the balloon was inadvertently expanded rather than pulling a negative to de-air the balloon, requiring the device to be re-prepped again correctly.Pre-dilatation was performed using a 3.0 non-compliant (nc) balloon.It was noted that to reach the lesion, the ivl balloon catheter was tracked through a pre-existing stent, and a pre-existing stent was also present within the intended treatment lesion, but the device would not fully cross to the distal end of the stent; the ivl balloon covered approximately 1/3 of the lesion.10 pulses were delivered, and the balloon was deflated and removed from the patient.Approximately 10 minutes post ivl treatment, the patient coded; an impella device was on standby for the procedure and was used to stabilize the patient.After the patient was stabilized, pre- dilatation was again performed using a nc scoring balloon.Following pre- dilatation with the nc balloon, the physician attempted to re-introduce the ivl device but it would not pass through the sheath.The patient was in the hospital, on the impella and intubated after the procedure, then reported to have expired approximately 5 or 6 hours later on the same day following the ivl 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
• MDR Report Key: 12505490
• Report Number: 3015053858-2021-00019
• Device Sequence Number: 20114260
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)230531(10)A210525N
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: 05/31/2023
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A210525N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.0 NC BALLOON; IMPELLA; NC SCORING BALLOON
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR