MAUDE Adverse Event Report: LIVANOVA USA INC. AORTIC ROOT CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	AR-19114
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova usa inc.Manufactures the aortic root cannula.The incident occurred in lubbock, texas.Through follow-up communication with the customer, livanova learned that the tip is still in the patient.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc.Received a report related to an aortic root cannula.The cannula was implanted in the patient by the surgeon and during this process it was noted that the tip broke off.The surgeon was not able to locate the tip and the tip remained with the patient.Affected unit was removed and replaced with another one.
Additional Manufacturer Narrative
H11: it was not possible to retrieve the product for investigation since it was retained by the customer.By reviewing the complaints database, no further event was recorded on this same lot out of (b)(4) manufactured units.No similar events were recorded on this specific product code.Dhr review was performed on the lot and no deviation or non-conformity was identified.The involved cannula tip is assembled to the y connector through the use of uv adhesive during manufacturing.Based on the available information, it cannot be excluded that an isolated operator error occurred during the assembly phase of this product due to insufficient adhesive application.To prevent re-occurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.
Event or Problem Description
See initial report.

• Brand Name: AORTIC ROOT CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20889860
• Report Number: 1718850-2024-00047
• Device Sequence Number: 18071542
• Product Code: DWF
• UDI-Device Identifier: 00803622103117
• UDI-Public: (01)00803622103117(240)AR-19114(17)260116(10)2301700011
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 01/16/2026
• Device Model Number: AR-19114
• Device Lot Number: 2301700011
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown