MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL

Model Number ONXACE-21

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446); Epistaxis (4458)

Event Date 09/07/2021

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 is accurate or has been confirmed by artivion.

Event Description

According to the initial report, the patient was hospitalized for a heart attack.They were also noted to have congestive heart failure, atrial fibrillation, hyponatremia (low level of sodium in the blood), and epistaxis (nosebleed).The event fully resolved after about 10 days.On 01/11/2023: receipt of patient's medical chart.Patient has history of coronary artery disease with myocardial infarction on (b)(6) 2022 with angioplasty, but no stenting of coronary arteries.

Event Description

According to the initial report through the live registry, the on-x low dose post approval registry patient (252) was hospitalized for a heart attack on (b)(6) 2022.The patient was also noted to have congestive heart failure, atrial fibrillation, hyponatremia (low level of sodium in the blood), and epistaxis (nosebleed).The event fully resolved after 10 days.On (b)(6) 2018 onxace-21 sn (b)(6) was implanted in the aortic position in a 70-year-old female patient who was subsequently enrolled in the on-x low dose post approval study (pas) as subject # 252.Two events were reported to the manufacturer; the first event was a myocardial infarction with angioplasty and the second event was an episode of severe epistaxis as a result of a supratherapeutic inr resulting in a hospital admission.Upon review of the patient¿s medical record, it was determined that the myocardial infarction with angioplasty occurred on (b)(6) 2022.The second event of severe epistaxis as a result of a supratherapeutic inr resulted in a hospital admission that occurred on (b)(6) 2022.Additionally, a complication adjudication was submitted by sidney levitsky, md for the myocardial infarction with angioplasty and it was determined to be unrelated to the valve.The complication adjudication from submitted by sidney levitsky, md for the bleeding event notates the event is unrelated to the valve.No additional information forthcoming.

Manufacturer Narrative

According to the initial report through the live registry, registry patient (252) was hospitalized for a heart attack on (b)(6) 2022.The patient was also noted to have congestive heart failure, atrial fibrillation, hyponatremia (low level of sodium in the blood), and epistaxis (nosebleed).The event fully resolved after 10 days.On (b)(6) 2018 onxace-21 sn (b)(6) was implanted in the aortic position in a 70-year-old female patient who was subsequently enrolled in the study as subject # 252.Two events were reported to the manufacturer; the first event was a myocardial infarction with angioplasty and the second event was an episode of severe epistaxis as a result of a supratherapeutic inr resulting in a hospital admission.Upon review of the patient¿s medical record, it was determined that the myocardial infarction with angioplasty occurred on (b)(6) 2022.The second event of severe epistaxis as a result of a supratherapeutic inr resulted in a hospital admission that occurred on (b)(6) 2022.Additionally, a complication adjudication was submitted by medical doctor for the myocardial infarction with angioplasty and it was determined to be unrelated to the valve.The complication adjudication form submitted by medical doctor for the bleeding event notates the event is unrelated to the valve.No additional information forthcoming.The manufacturing records for onxace-21 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.On (b)(6) 2018 onxace-21 sn (b)(6) was implanted in the aortic position in a 70-year-old female patient who was subsequently enrolled in the study as subject # (b)(6).On 6jan2023 two events were reported to the manufacturer; the first event was a myocardial infarction with angioplasty that occurred according to the patient on (b)(6) 2022 and the second event was an episode of severe epistaxis as a result of a supratherapeutic inr resulting in a hospital admission that occurred on (b)(6) 2022.This patient has an extensive medical history including but not limited to : coronary artery disease, aortic valve replacement with mechanical valve and mitral valve repair, atrial fibrillation, morbid obesity, congestive heart failure, chronic anticoagulation with coumadin and hypothyroidism.Regarding the event of myocardial infarction there is limited information available.This event is mentioned in the discharge records of the second event of epistaxis and was reported by the patient to her admitting physician.In the hospital record the following is noted ¿ reported myocardial infarction on (b)(6) 2022 with angioplasty but no stenting of coronary arteries as reported by patient¿, further information was requested but has yet to be received except an echocardiogram report dated 19aug2022.The report states regarding the prosthetic aortic valve : ¿ there is a prosthetic valve in the aortic position with normal function¿.This event was adjudicated as ¿other major hospitalization, cardiac related : mi with angioplasty, not valve related¿.On (b)(6) 2022 the patient was admitted to the hospital with severe epistaxis with a supratherapeutic inr of 5.2 on (b)(6) 2022 and 6.3 on (b)(6) 2022.She was maintained at an inr level of 2.0-3.0 starting in year three of the study and through the dates of both these events, prior to year three she was maintained at an inr 1.5-1.9.She was treated with vitamin k, holding of coumadin with a heparin bridge and placement of a rhino rocket.Her anticoagulation therapy was adjusted during the hospitalization to correct therapeutic levels.During this hospitalization she was also diagnosed and treated for an exacerbation of chf.She was discharged to short term rehab for therapy on (b)(6) 2022.This event was adjudicated as ¿major bleed, not valve related¿.The instructions for use [ifu] for the on-x valve lists both myocardial infarction and hemorrhage as potential adverse events for mechanical prosthetic valve recipients.Manufacturing records for this valve show a product meeting all requirements and acceptable for distribution.Myocardial infarction with angioplasty and epistaxis were both adjudicated by the on-x low dose post approval study (pas) complications adjudication committee(cac) as noted above, neither event was deemed valve related.The complaint has been reviewed for a capa evaluation.There is no indication that an error or deficiency occurred at artivion formerly cryolife and all risks identified have been mitigated as far as possible and residual risk is acceptable; therefore, a capa is not warranted at this time.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.D3 = changed artivion, inc.- austin to on-x life technologies, inc.G1 = changed artivion, inc.- austin to on-x life technologies, inc.

• Brand Name: ONX AORTIC CONFORM EXT 21
• 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: 16326384
• MDR Text Key: 309070293
• Report Number: 1649833-2023-00004
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 851788001457
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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 Operator: Lay User/Patient
• Device Expiration Date: 01/24/2024
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2018
• 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
• Treatment: COUMADIN, IV LASIX AND TORSEMIDE; COUMADINIV LASIXTORSEMIDE
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female