MAUDE Adverse Event Report: ARTIVION, INC. ¿ AUSTIN ONX AORTIC CONFORM EXT 27/29; HEART-VALVE, MECHANICAL

Model Number ONXACE-27/29

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Insufficient Information (4580)

Event Date 11/02/2022

Event Type  Injury  

Event Description

An implant registration card (onxace-27/29 sn (b)(4)) was returned from the user facility for a patient with an existing on-x heart valve (onxace-27/29 sn (b)(4)).Both ircs notate the valves were implanted in the aortic position suggesting the onxace-27/29 sn (b)(4) was explanted.This investigation is relegated to onxace-27/29 sn (b)(4).

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.

Manufacturer Narrative

A2 - date of birth (b)(6) 1986.G1 - manufacturing site facility name - on-x life technologies, inc.G3/g4 - pma/510(k)number - p000037.H10 - under "additional information narrative" the following statement has been updated to include the reference to the manufacturer."no medical records or operative notes were provided to the manufacturer and the explanted valve was not returned to the [manufacturer] for examination.".

Manufacturer Narrative

Under "additional information narrative" the following statement has been updated to include the reference to the manufacturer.No medical records or operative notes were provided to the manufacturer and the explanted valve was not returned to the manufacturer for examination.

Manufacturer Narrative

According to initial reports, an implant registration card (onxace-27/29 sn (b)(6) was returned from the user facility for a patient with an existing on-x heart valve (onxace-27/29 (b)(6) both ircs notate the valves were implanted in the aortic position suggesting the onxace-27/29 (b)(6) was explanted.This investigation is relegated to onxace-27/29 (b)(6) additional information received.According to the surgeon, "the valve was explanted for infection- no concern for valve defect itself.Patient is alive.Valve went to path.Path was consistent with endocarditis with an abscess.Grew staph aureus." the product will not be returned to the manufacturer for evaluation.The manufacturing records for the onxace-27/29 (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.An onxace 27/29 (b)(6) was implanted (b)(6) 2022 in a 35-year-old male with an unknown medical history.According to mandatory tracking information received by the manufacturer, this valve was explanted (b)(6) 2022 (28 days post-implant) and replaced with onxace 27/29 (b)(6) additional information from the surgeon indicated that the valve had been removed due to prosthetic valve endocarditis.¿the valve was explanted for infection -no concern for valve deficit itself¿ and ¿path was consistent with endocarditis with an abscess.Grew staph aureus¿.No medical records or operative notes were provided to the manufacturer and the explanted valve was not returned to the for examination.A review of the original manufacturing records shows no abnormalities.With the information available, the source of the endocarditis is unknown.However, because the on-x valve manufacturing process includes validated terminal sterilization prior to distribution¿verified by a review of manufacturing records unique to this valve¿the valve is unlikely to be the source of infection.The instructions for use (ifu) for the on-x valve states that reoperation, including explantation, may result from a complication, in this case, endocarditis, a known potential event acknowledged in the ifu.Though rare, historically, endocarditis occurs at a rate of 0.3 %/patient-year for mechanical aortic heart valves [iso 5840-2:2021].Endocarditis is the root cause for the explantation of the aortic on-x valve.Because all on-x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the infection.No further action is required.Endocarditis is the root cause for the explantation of the aortic on-x valve.Because all on-x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the infection.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 AORTIC CONFORM EXT 27/29
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC. ¿ AUSTIN; 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 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 16324682
• MDR Text Key: 309055885
• Report Number: 1649833-2023-00003
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001488
• UDI-Public: 851788001488
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/11/2023
• Date Manufacturer Received: 01/11/2023
• 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: 36 YR
• Patient Sex: Male