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

Model Number	C2IVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pericardial Effusion (3271)
Date of Event	04/04/2024
Type of Reportable Event	Death
Event or Problem Description
A shockwave c2 coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the left anterior descending artery.The procedure was completed successfully, followed by stenting.The patient was discharged from the hospital the next day.In that same afternoon, the patient was transported to the hospital again with cardiopulmonary arrest (cpa).Images showed that the lad stent was occluded and in a state of spontaneous awakening trials (sat).After the cpa urgent procedure was conducted, a left ventricular (lv) rupture and pericardial fluid occurred.The patient expired that night.The physician did not deny the causal relationship completely between ivl and the patient's death but also thinks other factors may be more significant.Lesion #6 was treated with the ivl catheter and stent.Lesion #7 was treated with a balloon catheter (bc) and stent.About 75 % stenosis remained distal to the stent in lesion #7.However, the 75 % stenosis was very tiny, so the physician decided not to treat the site and left it as it was.The physician believes this might have been related to the event.
Additional Manufacturer Narrative
The subject device was not returned for investigation.Therefore, a physical investigation of the device was not possible.The cause of the death could not be determined based on the information available.The physician believes the 75% stenosis that was left untreated might have been related to the subsequent occlusion and patient's death.There was no device malfunction reported on the ivl catheter.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.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to report new information received regarding concomitant devices as noted in section d10.

• 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: 19198169
• Report Number: 3015053858-2024-00037
• Device Sequence Number: 8360687
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)251130(10)01A231110A
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 11/30/2025
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: 01A231110A
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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: ALTA VIEW CATHETER (TERUMO); HIRYU PLUS 2.0/15 CATHETER (TERUMO); HIRYUPLUS2.5/12MM CATHETER (TERUMO); ONYX FRONTIER 2.0/26MM STENT (MEDTRONIC); ONYXFRONTIER 2.5/30MM STENT (MEDTRONIC)
• Outcome Attributed to Adverse Event: Hospitalization; Death; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female