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

Model Number ONXANE-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 05/23/2023

Event Type  Injury  

Event Description

According to the initial report an implant registration card (irc)was received for sn (b)(6)for a patient with an existing onxane-23 implanted.Additional information from the artivion field representative relayed "based on my conversation with the facility, this was not valve related and patient is doing great post-operatively!" additional information provided by the (b)(4) field representative collected from the hospital relayed, the on-x valve was implanted due to aortic stenosis and ascending aortic aneurysm.The patient is a 60 yowf who underwent an ascending aortic aneurysm repair with an avr and a cabg x 2 in (b)(6) 2023.She developed superficial drainage from her sternotomy incision which required antibiotics but ultimately resolved.She reports developing a tooth abscess for which she did not seek medical care around 2 weeks after her initial hospitalization for her initial surgery.She eventually presented last week (4 months after her initial surgery) with severe chest pain.An osh ct showed a periaortic hematoma.Her crp and wbc were elevated on admission here.Despite 1 week of iv abx, her crp remained elevated.Her bcxs ere[are] negative, and her tee showed no evidence of vegetations.A repeat ct chest showed an interval development of an aortic pseudoaneurysm at the site of her aortic graft.She now presents for urgent surgical resection of the pseudoaneurysm and replacement of her prostheses.The patient is currently doing well and is undergoing cardiac rehab classes.No additional information is forthcoming.

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 (b)(4).

Manufacturer Narrative

The manufacturing records for onxane-23 sn (b)(6) were reviewed.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 18110 and 18115 were issued for leaflet tuning as a part of the standard manufacturing process.According to mandatory tracking information received by the manufacturer this patient was implanted with a second on-x valve in the aortic position 113 days after her initial implant.Onxane-23 sn (b)(6) was implanted with concomitant procedures of an ascending aortic aneurysm repair and a coronary bypass graft x2 on (b)(6) 2023 in a 60-year-old female patient.On 15june2023, we received the information that the second valve onxace -23 sn (b)(6) was implanted on (b)(6) 2023 in the aortic position.During the investigation we contacted the surgeon and his staff and were given the following information: the patient presented to the emergency room approximately 4 weeks after implant with complaints of chest pain.A ct of the chest was performed that showed a periaortic hematoma.In addition, the patients wbc and crp were both elevated upon admission.The patient was admitted to the hospital and treated with iv antibiotics for 1 week, at the end of the antibiotic regimen her crp remained elevated, but her blood cultures grew out negative.A tee [transthoracic echocardiogram] performed during her admission showed no vegetations.At the conclusion of the antibiotic regimen a repeat ct of the chest was performed that showed interval development of pseudoaneurysm at the site of the aortic graft.The decision was then made to urgently take the patient back to the operating room and perform a surgical resection of the pseudoaneurysm and replace the prosthetic aortic valve onxane-23 sn (b)(6).We were informed that the surgery was successful, and the patient is now doing well in cardiac rehab classes.Addition information obtained included an event of possible significance, the patient reported she had a tooth abscess approximately 2-week post implant and that she did not seek medical treatment at the time.There was no claim regarding the valve having malfunctioned and a review of manufacturing records show no processing issues.The valve was not returned to the manufacturer for examination.The instructions for use [ifu] for the on-x valve acknowledge the possibility of reoperation and explantation due to complications.The development of a pseudoaneurysm at the site of the ascending aortic aneurysm repair where the aortic graft was located is the cause of the reoperation and let to the replacement the on-x aortic valve.The possibility that the reported untreated tooth abscess led to the development of the beginning stages of endocarditis and therefore a weakening of the aortic graft repair cannot be ruled out.There is no indication that the on-x valve failed to function as designed.Diagnosis of pseudoaneurysm at the aortic graft site requiring the surgical resection and subsequent explant and implant of a new valve.There is no indication that the on-x valve failed to perform as designed.Diagnosis of pseudoaneurysm at the aortic graft site requiring the surgical resection and subsequent explant and implant of a new valve.There is no indication that the on-x valve failed to perform as designed.There is not sufficient data to determine a valve failure mode: thus, severity and occurrence is not evaluated.Each individual hazard is mitigated and reduced as low as possible by design and process.Postproduction residual risk is communicated in the product¿s labeling and ifu (instructions for use).The root cause was determined to be development of a pseudoaneurysm.The pseudoaneurysm at the site of the ascending aortic aneurysm repair where the aortic graft was located is the cause of the reoperation and let to the replacement the on-x aortic valve.The possibility that the reported untreated tooth abscess led to the development of the beginning stages of endocarditis and therefore a weakening of the aortic graft repair cannot be ruled out.There is no indication that the on-x valve failed to function as designed.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.

Event Description

According to the initial report an implant registration card (irc)was received for sn (b)(6) onxace-23 for a patient with an existing onxane-23 implanted.Additional information from the artivion field representative relayed "based on my conversation with the facility, this was not valve related and patient is doing great post-operatively!" additional information provided by the artivion field representative collected from the hospital relayed, the on-x valve was implanted due to aortic stenosis and ascending aortic aneurysm.The patient is a 60 yowf who underwent an ascending aortic aneurysm repair with an avr and a cabg x 2 in (b)(6) 2023.She developed superficial drainage from her sternotomy incision which required antibiotics but ultimately resolved.She reports developing a tooth abscess for which she did not seek medical care around 2 weeks after her initial hospitalization for her initial surgery.She eventually presented last week (4 months after her initial surgery) with severe chest pain.An osh ct showed a periaortic hematoma.Her crp and wbc were elevated on admission here.Despite 1 week of iv abx, her crp remained elevated.Her bcxs ere[are] negative, and her tee showed no evidence of vegetations.A repeat ct chest showed an interval development of an aortic pseudoaneurysm at the site of her aortic graft.She now presents for urgent surgical resection of the pseudoaneurysm and replacement of her prostheses.The patient is currently doing well and is undergoing cardiac rehab classes.No additional information is forthcoming.

• Brand Name: ONX AORTIC ANATOMIC EXT 23
• Type of Device: 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 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17244390
• MDR Text Key: 318264696
• Report Number: 1649833-2023-00019
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001662
• UDI-Public: 851788001662
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: ONXANE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/02/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2022
• 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): Other
• Patient Age: 60 YR
• Patient Sex: Female