MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC ANATOMIC EXT 23; HEART-VALVE, MECHANICAL

Model Number	ONXANE-23
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to the initial report received onxane -23 serial number:(b)(6) was explanted on (b)(6) 2023.
Event or Problem Description
According to the initial report received onxane -23 serial number: (b)(6) was explanted on (b)(6) 2023.Multiple attempts to obtain additional information have gone unmet.This investigation is relegated to onxane -23 serial number: (b)(6).
Additional Manufacturer Narrative
The manufacturing records for onxane-23 sn (b)(6) were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.Change orders le (b)(4) were issued for leaflet tuning as a part of the standard manufacturing process.During the investigation no non-conformances or deviations were identified.On (b)(6) 2018 an onxane-23 sn (b)(6) was used in a case for a 26-year-old female in the aortic position.A second aortic on-x was reported to device tracking as implanted in the same position, same patient: (b)(6) 2023 onxane-23 sn (b)(6) (1,660 days post-implant).Multiple attempts to receive additional information received no response.Review of manufacturing records show no processing issues with the original valve.The valve was not returned to the manufacturer for examination.We have no information about the explanted on-x valve other than the tracking notice and assume the valve was discarded on site.Consequently, we do not have enough information to know what, if any, contribution the valve had to the decision to replace it.The instructions for use for the on-x valve lists the possibility of explantation as a consequence of a complication of prosthetic heart valve replacement [ifu].But in this instance, we do not have any information to help us identify that complication.There is not enough information to determine what, if any, contribution the on-x valve had to the decision for its removal.The review of manufacturing records show no processing issues with the original valve.The valve was not returned to the manufacturer for examination.We have no information about the explanted on-x valve other than the tracking notice and assume the valve was discarded on site.Consequently, we do not have enough information to know what, if any, contribution the valve had to the decision to replace it.The instructions for use for the on-x valve lists the possibility of explantation as a consequence of a complication of prosthetic heart valve replacement [ifu].But in this instance, we do not have any information to help us identify that complication.There is not enough information to determine what, if any, contribution the on-x valve had to the decision for its removal.There is not sufficient data to determine a valve failure mode; thus, severity and occurrence is not evaluated.The root cause was determined to be unknown.There is no information about the explanted on-x valve.Adequate information is not present to know what, if any, contribution the valve had to the decision for it to be replaced.This event does not identify additional hazards or modify the probability and severity of existing hazards, and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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 (b)(4).

• Brand Name: ONX AORTIC ANATOMIC EXT 23
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 79752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17244179
• Report Number: 1649833-2023-00018
• Device Sequence Number: 17850260
• Product Code: LWQ
• UDI-Device Identifier: 00851788001662
• UDI-Public: 851788001662
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: Lay User/Patient
• Device Expiration Date: 06/06/2024
• Device Model Number: ONXANE-23
• 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: 06/03/2023
• Supplement Date Received by Manufacturer: 06/03/2023
• Initial Report FDA Received Date: 07/01/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2018
• 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 Age: 31 YR
• Patient Sex: Female