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	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2 coronary intravascular lithotripsy (ivl) catheter was used to treat the left main (lm) and the left anterior descending artery (lad).A kissing balloon technique was utilized for the procedure.Access to the target vessel(s) was obtained via the right femoral artery (rfa).The ivl catheter was inserted into the patient with a 7f guide catheter.The ivl catheter successfully delivered 80 pulses with post dilation with a 3.5 balloon catheter to the lm and lad.A 3.5 × 12mm xience skypoint stent was implanted to the lm and a 2.25 x 15mm resolute onyx stent was implanted in the lad.A stent malposition was observed and a 5.0 balloon catheter was utilized to dilate the stent at the proximal site.A coronary perforation occurred at left main trifurcation (lmt) distal.During ivus imaging, it was observed that there was a hematoma at the proximal left circumflex artery (lcx).The hematoma caused a slow flow.The physician implanted a hemostasis stent (covered stent) to complete the procedure.The patient was discharged four days post procedure.There was no shockwave device problem reported with the adverse event.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical inc.For investigation therefore, no device inspection could be performed.Based on the reported information, there was no shockwave device malfunction.The cause of the reported perforation and hematoma experienced by the patient could not be determined as the device was not returned.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.

• 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 (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 ; 8777754846
• MDR Report Key: 18660965
• Report Number: 3015053858-2024-00008
• Device Sequence Number: 15507109
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)241231(10)A221207D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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: 12/31/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A221207D
• 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: 01/12/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• 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: 2.25 X 15MM RESOLUTE ONYX DES; 3.5 BALLOON CATHETER-UNKNOWN MANUFACTURER; 3.5 X 12MM XIENCE SKYPOINT DES; 7F GUIDE CATHETER; HEMOSTASIS STENT-UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian