MAUDE Adverse Event Report: ARTIVION, INC. ¿ AUSTIN ONX MITRAL STANDARD 31/33; HEART-VALVE, MECHANICAL

Model Number ONXM-31/33

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Valvular Insufficiency/ Regurgitation (4449); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/03/2022

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 ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

Event Description

Implant summary card for onxm-31/33, sn (b)(4) was received back from the user facility.Implant date (b)(6) 2022.Upon entering the information into the device tracking database, onxm-31/33, sn (b)(4) exists for this same patient.Implant date (b)(6) 2022.This investigation is relegated to onxm-31/33, sn (b)(4).

Manufacturer Narrative

Implant summary card for onxm-31/33 sn (b)(6) was received back from the user facility, with an implant date of 3oct2022.A previous implant for this patient was found in the device tracking database.Onxm-31/33 sn (b)(6) was implanted (b)(6) 2022 in the same position.The product will not be returned to the manufacturer for evaluation.This investigation is relegated to onxm-31/33 sn (b)(6).According to additional information "there was nothing wrong with the valve.He [pa] remembers it being a paravalvular leak, likely due to implantation technique." no additional information forthcoming.The manufacturing records for the onxm-31/33 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.A review of the available information was performed.On (b)(6) 2022 an onxm 31/33 sn (b)(6) was used in a case for a 77-year-old male in the mitral position.A second aortic on-x was reported to device tracking as implanted in the same position, same patient: (b)(6) 2022 onxm 31/33 sn (b)(6)(54 days post-implant).Review of manufacturing records show no processing issues.The valve was not returned to the manufacturer for examination.A reply from artivion employee was received after a conversion with the pa regarding this case; ¿he said there was nothing wrong with the valve.He remembers it being a paravalvular leak, likely due to implantation technique¿.With this information we can conclude that an issue with the valve itself did not lead to its removal, rather a paravalvular leak due to implantation technique led to the removal of the valve according to the pa at the implanting hospital.With the provided additional information we can conclude that an issue with the on-x valve did not contribute to the reason for removal and replacement.No further action is required.With the provided additional information we can conclude that an issue with the on-x valve did not contribute to the reason for the removal and replacement.The manufacturing records 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.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.Artivion 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 ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

• Brand Name: ONX MITRAL STANDARD 31/33
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 16280401
• MDR Text Key: 308590897
• Report Number: 1649833-2023-00002
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 851788001303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXM-31/33
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/03/2023
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 71 YR
• Patient Sex: Male