MAUDE Adverse Event Report: LIVANOVA USA INC CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	AR-XXXXX
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: no patient information was provided a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device availability has not been clarified.Investigation is ongoing.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has been informed that, during the administration of the cardioplegia through the cardioplegia cannula ar-11114, medical team could not administer the cardioplegia, the aortic cross clamp had to be released, the cannula was extracted and the tip found kinked.No information of patient outcome was provided.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Review of the dhr for the claimed lot did not identify any deviations, non-conformities, or material scrap/requests relevant to the reported issue.The root cause of the kink is unknown.To improve the resistance to kinking during the application, livanova has compared the aortic root cannula with other non livanova similar aortic root finding other cannula present thicker tip.Increasing the thickness should improve resistance to kink.In addition, it was found that, the conicity in the complained tip is constant along the tip while other tips of similar aortic root are characterized by an increase of conicity towards the distal extremity.Increase of the conicity should enhance the smooth insertion within the aortic wall.The investigation that livanova has opened to address the root cause(s) of the kink of this cannula could not identify any specific root cause.No device malfunction could be confirmed.No new hazard has been identified: the failure is described in the relevant risk management file of the products.In details, when a tip kinks or bends, the cannula behaves as a cannula with a clogged tip.According to the relevant risk management file, when the tip of the cannula is clogged, the flow or venting may be reduced or prevented.A patient harm can occur if the patient is not monitored, and the failure remains undetected.However, patients are continuously monitored during the procedures.Accordingly, these failures were noted, the devices replaced, and no harm to patient has ever occurred.According to livanova procedure, the patient overall risk level (the combination of the probability level incredible and the severity critical), is considered acceptable.As the residual risk is in the acceptable region, no action on the market is deemed necessary.Despite the root cause of the kink is unknown, the risk is acceptable and no malfunction of the device could be identified, livanova has planned to improve the tip of the device by increasing the wall thickness and by improving the conicity on the external surface.Livanova wil keep monitoring the market.
Additional Manufacturer Narrative
During a dekra audit, livanova has identified that submitted report did not clarify that investigation that livanova has opened to address the root cause(s) of the kink of this cannula suggested that the issue is associated to the intrinsic characteristic of the cannula.Despite the risk is in the acceptable region, to improve resistance to kinking during the application, livanova has planned to improve the tip of the device by increasing the wall thickness and by improving the conicity on the external surface.The present report is being submitted to provide this clarification.The improvement activities are planned for completion by q2 2022.
Event or Problem Description
See intial report.

• Brand Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• 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: 12041599
• Report Number: 1718850-2021-00035
• Device Sequence Number: 11811998
• Product Code: DWF
• UDI-Device Identifier: 00803622103056
• UDI-Public: (01)00803622103056(240)AR-11114(17)240229(10)2103200008
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 12/02/2021

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: 02/29/2024
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-11114
• Device Lot Number: 2103200008
• 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: 05/27/2021
• Supplement Date Received by Manufacturer: 09/02/2021; 09/02/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/29/2021; 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2021
• 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: Required Intervention
• Patient Sex: Unknown