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	03/01/2024
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+ intravascular lithotripsy (ivl) catheter was used to treat a lesion in the left circumflex artery (lcx).The ivl catheter successfully delivered 120 pulses.There was no report of an ivl device malfunction.This event was sent to the clinical events committee (cec) for adjudication of the patient's myocardial infarction.The cec indicated that film was reviewed and loss of side branch was observed with creatine kinase-mb (ck-mb) levels greater than 10x the upper normal limit (uln) within 48 hours of the procedure.Cec has determined that myocardial infarction is possibly related to the study device and definitely 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 myocardial infarction could not be definitively determined based on the information available.There was no ivl malfunction reported.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: 20214553
• Report Number: 3015053858-2024-00102
• Device Sequence Number: 7858071
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)250831(10)01A230821A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/13/2024

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: 08/31/2025
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 01A230821A
• 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: 08/16/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2023
• 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: POST-DILATATION CATHETER - BIOTRONIK; POST-DILATATION CATHETER - MEDTRONIC; POST-STENT DILATION CATHETER -UNKNOWN MANUFACTURER; POST-STENT DILATION CATHETER -UNKNOWN MANUFACTURER; POST-STENT DILATION CATHETER -UNKNOWN MANUFACTURER; POST-STENT DILATION CATHETER -UNKNOWN MANUFACTURER; PRE-DILATATION CATHETER - ABBOTT; PRE-DILATATION CATHETER - BIOTRONIK; PRE-DILATATION CATHETER - BIOTRONIK; PRE-DILATATION CATHETER - BIOTRONIK; PRE-DILATATION CATHETER - TERUMO; XIENCE SKYPOINT DRUG ELUTING STENT (DES) - ABBOTT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female