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The manufacturing records for onxane-27/29 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 18097 and lw18226 were issued for leaflet tuning as a part of the standard manufacturing process.On 12july2023 an onxane-27/29 sn (b)(6) was used in a case for a 61-year-old male patient in the mitral position instead of the correct mitral on-x valve.The surgeon noticed this during the surgical report and took the patient back to the operating room to explant the incorrect aortic valve and implant a mitral valve onxm -25 sn (b)(6) and the patient did not survive the reoperation.The timeline of events is as follows: on 1aug2023 a product concern email was submitted by the hospital staff ¿ label is insufficient on the box and the sticker inside to indicate either aortic or mitral valve.Need packaging and sticker inside the box for reordering to be more obvious for visual cue.¿ a sales representative responded the next day 2aug2023 with an attached product catalog for reference, the sales representative also informed field assurance of the product concern email.On 16aug2023 a meeting was held at the request of the hospital staff and the provincial health services authority to discuss their labeling concerns and the sales representative and members of the field assurance team attended.During this meeting, we were informed for the first time there was a patient impact related to the labeling issue raised by the hospital.Additional information was requested, and an updated field assurance form was completed by the sales representative stating that the on-x aortic valve implanted on 12july2023 onxane 27/29 sn (b)(6) was on the mitral cart in the or, the nurse picked the 27/29 aortic valve from the cart, and it was implanted in the mitral position.The surgeon noticed the improper valve was used during the surgical report and took the patient back to the or to explant the aortic valve and implant the correct mitral valve onxm -25 sn (b)(6).The patient did not survive the reoperation and according to the hospital representatives the nurse and assistant are being investigated.The hospital requested we change the labeling of the aortic and mitral valves to make ease of identifying easier and after an internal review it was determined that the labeling is sufficient and will not be altered at this time.To help prevent such an error from occurring again the sales representative is providing in-service and training to hospital staff.Review of manufacturing records show no processing issues with the original valve.The valve was not returned to the manufacturer for examination and no patient specific medical records were provided for review.The instructions for use for the on-x valve lists the possibility of explantation and death as a consequence of prosthetic heart valve replacement [ifu].In this case the on-x valve did not contribute in any way to the decision to explant and the subsequent death and in fact, the sole reason for the explant was due to errors made by hospital staff causing the implantation of the incorrect aortic valve in the mitral position.In- service of hospital staff by the sales representative to educate on correctly identifying labels of all on-x heart valve products to include aortic, mitral and aap devices.In this case the on-x valve did not contribute in any way to the decision to explant and the subsequent death and in fact, the sole reason for the explant was due to errors made by hospital staff causing the implantation of the incorrect aortic valve in the mitral position.A product failure is not identified; thus, severity and occurrence is not evaluated.The root cause of the inattention to package labeling.The labeling has been evaluated, and it was determined that the valves were labeled appropriately.No action to change labeling/packaging at this time.Adequate precautions regarding risk of mis-identifying the valve type are provided in the ifu.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 and the ifu adequately communicates risk.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.
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