MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number	ONXMC-25/33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received via email on 08 sept 2023, a on-x mitral implant registration card returned from the user facility is for a patient with an existing on-x mitral valve implanted.The patient had onxmc-25/33 serial number: (b)(6) implanted on (b)(6) 2021.The valve was explanted for an unknown issue on (b)(6) 2023.The investigation is on-going.
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 via email on 08sept2023, a on-x mitral implant registration card returned from the user facility is for a patient with an existing on-x mitral valve implanted.The artivion field representative replied to the request for additional information as follows "i tried several times to get info on this valve, but never received a response.There was never a complaint from the surgeon or anyone else about this valve." no additional information forthcoming.This investigation is relegated to onxmc-25/33.Serial number: (b)(6).
Additional Manufacturer Narrative
The manufacturing records for serial number (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.During the investigation no non-conformances or deviations were noted.Document change orders le17685 and le17849 were issued for leaflet tuning as a part of the standard manufacturing process.On (b)(6) 2021 an onxmc 25/33 sn (b)(6) was used in a case for a 48-year-old male in the mitral position.A second mitral on-x was reported to device tracking as implanted in the same position, same patient: (b)(6) 2023 onxmc 25/33 sn (b)(6) (707 days post-implant).Attempts to receive additional information received no response.Review of manufacturing records show no processing issues.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.After multiple attempts to obtain additional information, we completed this report with the limited available information.As such the determination was made that 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 failure mode; thus, severity and occurrence is not evaluated.No further action is required without additional information.The root cause is unknown.After multiple attempts to obtain additional information, we completed this report with the limited available information.As such the determination was made that there is not enough information to determine what, if any, contribution the on-x valve had to the decision for its removal.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 artivion.

• Brand Name: ONX MITRAL CONFORM 25/33
• 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; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17885532
• Report Number: 1649833-2023-00037
• Device Sequence Number: 7289544
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 851788001303
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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 Model Number: ONXMC-25/33
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2021
• 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 Age: 50 YR
• Patient Sex: Male