MAUDE Adverse Event Report: ARTIVION, INC. ¿ KENNESAW ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL

Model Number ONXM-25

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/14/2015

Event Type  Injury  

Event Description

Patient was a participant in the prose study, subject id ¿dcm 022¿.He had a diagnosis of rheumatic heart disease with moderate mitral regurgitation, severe pah, severe tr, la aneurysmally dilated and required mitral valve replacement.14 nov 2015 - valve thrombosis diagnosed.Patient was thrombolysed; post fluoroscopy showed one leaflet fully released, the other leaflet partially.Was discharged in stable condition on (b)(6) 2015.This investigation is relegated to onxm-25 sn (b)(4).Patient's historical inr: (b)(6) 2015 1.21.(b)(6) 2015.(b)(6) 2015 4.36.(b)(6) 2025 4.47.

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

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.According to initial reports, ¿patient was a participant in the prose study.He had a diagnosis of rheumatic heart disease with moderate mitral regurgitation, severe pah, severe tr, la aneurysmally dilated and required mitral valve replacement.He voluntarily participated in the study by signing informed consent form for the study on (b)(6) 2015.(b)(6) 2015 - valve thrombosis diagnosed.Patient was thrombolysed; post fluoroscopy showed one leaflet fully released, the other leaflet partially.Was discharged in stable condition on (b)(6) 2015.¿ this investigation is relegated to onxm-25 sn (b)(6).Patient's historical inr (b)(6), 2015 1.21, (b)(6) 2015, (b)(6) 2015 4.36 ,(b)(6), 2015 4.47.At the time of this event, the valve remained implanted.The valve was not returned to the manufacturer.Additionally, the patient passed (b)(6), 2019.An investigation into the event can be found in complaint (b)(4) (manufacturer report number ¿ 1649833-2022-0047).Both events were submitted simultaneously.The manufacturing records for the onxm-25 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 by clinical research/medical directors.On (b)(6) 2015 an approximately 16-year-old male, was consented into the prose [prospective randomized on-x vs.Sjm medical evaluation] study by his father; was randomized into the on-x arm and underwent a mitral valve replacement with concomitant tricuspid valve repair.The valve implanted was onxm- 25 sn (b)(6).The patient had a past medical history of rheumatic heart disease with moderate mitral regurgitation, severe pah [pulmonary arterial hypertension], la [left atrium] aneurysmally dilated and severe tricuspid insufficiency that required a mitral valve replacement and tricuspid valve repair.He was discharged on warfarin only.The patient was followed and on (b)(6) 2016 during his 6 months follow up visit it was reported that on (b)(6) 2015 (156 days post implant) the patient complained of dyspnea and vomiting and was admitted to the hospital for a total of 12 days.An echocardiogram was performed, and he was diagnosed with prosthetic valve thrombosis.He was thrombolized with stk and the post thrombolysis fluoroscopy showed adequate movement of one leaflet.Inr at the time of the event was recorded as 4.38 on (b)(6) 2015.The patient was discharged home on medical management in stable condition with only one fully functioning leaflet and asa was added to his home medications.No further information on this event is available.This prosthesis thrombosis might be a consequence of inadequate anticoagulation compliance as inr history is not available other than the one level at the time of the event.Thrombosis is a rare, but a known potential complication of prosthetic valve replacement occurring at a historical rate of 0.2% per patient-year for mechanical mitral heart valves [iso 5840-2:2021 (e)].It is recognized as a potential adverse event for the on-x valve along [ifu].Root cause for this event is prosthetic valve dysfunction (restriction of leaflets movement) related to thrombus.Unknown anticoagulation compliance history may be a contributing factor.No further action is required.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.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.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, no further action is warranted at this time.

Manufacturer Narrative

H10 - additional manufacturer narrative this prosthesis thrombosis might be a consequence of inadequate anticoagulation compliance as inr history is not available other than the levels reported at the time of the event (4.41 and 4.38 on 14nov2015 and 2.58 on 16nov2015).

• Brand Name: ONX MITRAL STANDARD 25
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15369810
• MDR Text Key: 299369301
• Report Number: 1649833-2022-00046
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/10/2022
• Date Manufacturer Received: 08/10/2022
• 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; Other; Hospitalization
• Patient Age: 23 YR
• Patient Sex: Male