MAUDE Adverse Event Report: ARTIVION, INC. ¿ AUSTIN ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXANE-23

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Stroke/CVA (1770); Headache (1880); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2022

Event Type  Injury  

Event Description

Patient is subject in the on-x post approval study.(b)(6) 2022 - patient developed a headache and left sided weakness.He was seen by stroke consultant - was alert, no facial weakness, no visual field loss.Stuttering speech is normal for him.Mild left arm drift which resolved the next day.He has been seen by pt/ot and discharged with no further needs.We started bridging therapy to ensure inr was above 2 before discharging on warfarin.Inr on discharge was 2.The anti coagulant team updated us that the target inr has been reduced to 1.8 with a range of 1.5 to 2.He is currently waiting a neurology outpatient review.We held statin due to a rise in alp - gp to repeat bloods - lfts still deranged for liver uss.He is mffd.This event is relegated to onxane-23 5548916.

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

According to initial reports, a complication was entered in the live registry on (b)(6) 2022.Patient in the on-x low dose post approval registry, ¿patient developed a headache and left sided weakness.He was seen by stroke consultant - was alert, no facial weakness, no visual field loss.Stuttering speech is normal for him.Mild left arm drift which resolved the next day.He has been seen by pt/ot and discharged with no further needs.We started bridging therapy to ensure inr was above 2 before discharging on warfarin.Inr on discharge was 2.The anti-coagulant team updated us that the target inr has been reduced to 1.8 with a range of 1.5 to 2.He is currently waiting a neurology outpatient review.We held statin due to a rise in alp - gp to repeat bloods - lfts still deranged for liver uss.He is mffd.¿ information regarding valve relation incomplete.A complication adjudication form was completed (b)(6) 2022 and submitted to field assurance september 8, 2022.The event is notated to be related to the valve.Medical notes were received and cover the patient¿s medical history from january 2022 through september 2022.The device will not be returned as it remains implanted.This investigation is relegated to the onxane-23 sn (b)(6) , event date march 9, 2022.The manufacturing records for the onxane-23 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) 2019 onxane-23 sn (b)(6) was implanted in the aortic position in a 56-year-old male patient who was subsequently enrolled in the on-x low dose post approval study (pas).On (b)(6) 2022 three events were reported to the sponsor, of those events two were adjudicated as valve related.The two valve related events occurred on (b)(6) 2022 recorded as a complaint of ¿weakness of left leg and headache¿ and on (b)(6) 2022 recorded as a complaint of ¿headache and left side weakness¿.The third event deemed non-valve related occurred on (b)(6) 2022 and was recorded as ¿patent deliberately cut left wrist¿.On (b)(6) 2022 (957 days post implant) the patient reported to the accident and emergency department with the complaint of ¿left leg giving way and numb and weak since this morning when he wakes up, headache yesterday, h/o cva 3-4 months ago¿.He was evaluated by the stroke team, labs and ct of the head were performed and he was discharged home with a note in the file ¿symptoms are worsening of current symptoms and not new¿.The ct of the head showed ¿no significant intracranial abnormality¿ and none of the lab work results were provided, however an inr of 1.8 was provided when reported to the sponsor.The event was adjudicated as ¿hospitalization with tia, no cva, te event¿ and ¿valve related¿.On (b)(6) 2022 (1,003 days post implant) the patient reported to the accident and emergency department with the complaint of ¿headache and left side weakness¿ and it is noted that this patient has had multiple admissions with similar symptoms.He was admitted to the inpatient unit and evaluated by the stroke consultant, and an mri and ct of the head were both performed with no acute intracranial findings.No inr was provided at the time of his admission; however, his discharge notes state that his inr on discharge was 2 with a target inr of 1.8, range of 1.5-2.0.That range is appropriate for a participant in the pas (target inr 1.5 ¿ 2.0).His discharge diagnosis was ¿probable functional weakness¿ and it is also noted in the patient education section of his discharge summary that the ¿diagnosis of probable functional weakness¿ due to a number of issues? migraine? stress and anxiety.We explained that he has not had a stroke¿.He was referred to neurology for follow up and the evaluation was completed on (b)(6) 2022 and stated in the notes ¿he has had an mri scan of the brain showing no significant abnormalities, although the referral stated that he had micro-hemorrhages.I have reviewed the scan today and there was no evidence of micro-bleeds.I understand that the symptoms were thought to be of functional nature¿ the event was adjudicated as ¿hospitalized with tia, cva ruled out, considered te event¿ and ¿valve related¿.The instructions for use [ifu] for the on-x valve lists thromboembolism as a potential adverse event for mechanical prosthetic valve recipients.If thromboembolism is the underlying cause of the tia, it occurs at a historical rate of 3.0% per patient-year for rigid heart valves [iso 5840:2021[e].Probable tia, possibly valve related due to the requirement for anticoagulation, but could also be related to or exacerbated by previous cva or diagnosis of probable functional weakness.No further action is required.Based on the available information, a definitive root cause for this event cannot be determined.However, probable tia, possibly valve related due to the requirement for anticoagulation, but could also be related to or exacerbated by previous cva or diagnosis of probable functional weakness.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, no further action is warranted at this time.D4 - model number - onxane-23.

• Brand Name: ONX AORTIC CONFORM EXT 23
• 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: 15540235
• MDR Text Key: 301156861
• Report Number: 1649833-2022-00050
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001662
• UDI-Public: 851788001662
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXANE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/06/2022
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male