MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AAP UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number ONXAAP UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.

Event Description

According to the initial information received via email on 21dec2023, "i have just been notified of a possible allergy after an aap implant in croatia." additional information stated "one patient develop an allergy reaction after onx conduit implantation.They will test him tomorrow to see on what he developed reactions.".

Manufacturer Narrative

The manufacturing records for onxaap valve were unable to be reviewed as a serial number could not be obtained.On (b)(6) 2023 an email was received from (b)(6)., an artivion north & central european sales manager with the following information, "i have just been notified of a possible allergy after an aap implant in croatia." after further inquiry (b)(6) received the following additional information from a.V.With macs medical "one patient develop an allergy reaction after onx conduit implantation.They will test him tomorrow to see on what he developed reactions." the device size and serial number is unknown and no further information was provided, including medical records or results of the follow-up allergy testing.The on-x aap consists of an on-x aortic mechanical heart valve composed of a graphite substrate coated with on-x carbon, a pure unalloyed form of pyrolytic carbon.The sewing cuff is constructed of ptfe fabric mounted using titanium retaining rings and 5-0 polyester suture material.The gelweave valsalva vascular prosthesis is a woven polyester prosthesis impregnated with an absorbable protein made of modified mammalian gelatin.The gelatin is a non-antigenic and non-toxic protein as reflected in its use as a safe plasma expander.In this case we cannot confirm the report of allergic reaction to the onxaap device with the information provided as we cannot rule out reactions to other materials used during the procedure or positively link the report of allergic reaction to any material in the onxaap device.A search of past complaints yielded no other cases of allergic reaction to either the on-x valve alone or to the onxaap device.With the available information, it is unknown what, if any, contribution the onxaap had to the report of unknown allergic reaction.However, the risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu (instructions for use).A product failure mode cannot be identified; thus, severity and occurrence is not evaluated.With the lack of information available from health care professionals, artivion cannot confirm the report of allergic reaction to the onxaap device.Also, artivion cannot rule out reactions to other materials used during the procedure or positively link the report of allergic reaction to any material in the onxaap device.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.References: on-x® ascending aortic prosthesis with the vascutek gelweave valsalvatm graft, instructions for use.Http://www.Onxlti.Com/ifu/.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.

• Brand Name: ON-X AAP UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18517164
• MDR Text Key: 332911314
• Report Number: 1649833-2024-00002
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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
• Device Model Number: ONXAAP UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention