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

Model Number ONXAAP-23

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

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729)

Event Date 03/14/2021

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 ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

Event Description

According to aap study - ascend - post market clinical follow-up study in patients treated with the on-x ascending aortic prosthesis (aap) adverse event report, event details: implant date - (b)(6) 2021.Patient age at time of event: 64 yo.Adverse event classification: this event is not linked to the medical device ¿ non-serious (ae).Detailed description of event: no information provided.Outcome of event: no information provided.Information on taken actions because of event: no information provided.Assessment by investigator: no information provided.Adverse event - cardiac arrhythmia.Classification ¿ adverse event.Start date ¿ ((b)(6), 2021.End date ¿ (b)(6), 2021.Duration of event ¿ 0.Outcome ¿ symptoms resolved without sequelae.Causal relationship to the procedure ¿ possible.Causal relationship to the aortic valve disease of heterogeneous ethology ¿ possible.Causal relationship to on-x aap ¿ possible.Number of reoperations performed: 0.This investigation is relegated to onxaap-23 sn(b)(4).

Manufacturer Narrative

H10 - additional manufacturer narrative.The date of implant is (b)(6) 2021, corrected from (b)(6) 2021.

Manufacturer Narrative

According to initial reports, patient in ascend - post market clinical follow-up study in patients treated with the on-x ascending aortic prosthesis (aap), experienced cardiac arrhythmia.This investigation is relegated to onxaap-23 sn(b)(6).The product will not be returned to the manufacturer for evaluation as it remains implant.Additional information regarding this event was received.The manufacturing records for the onxaap-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.An onxaap 23 with serial number (b)(6)was implanted on (b)(6) 2021 in a 64-year-old male with a past medical history of tobacco abuse, obesity, hypertension, hyperlipidemia, coronary artery disease and atrial fibrillation with a direct current cardioversion [dccv] on (b)(6) 2021, severe aortic stenosis with bicuspid valve and proximal ascending aortic dilation.On (b)(6) 2021 (5 days post implant) the patient was noted to have a heart rhythm on the cardiac monitor of atrial fibrillation with rvr in the 140¿s and reported palpitations.His metoprolol was increased to 25mg twice daily and he was given an iv amiodarone bolus and started on an oral amiodarone titration regimen.The event lasted less than one day per the medical records.On his follow up visit on (b)(6) 2022 (338 days post implant) the notes state that the patient has no recurrent episodes of atrial fibrillation and is no longer on amiodarone.The instructions for use [ifu] for the aap valve list cardiac arrhythmia as a potential adverse event for mechanical prosthetic valve recipients.There is no indication that the on-x valve contributed in any way to the reported episode and it is more likely a complication related to the surgical procedure itself rather than the valve.Cardiac arrhythmia is a known potential complication, however, there is no indication that the on-x valve contributed in any way to the reported episode and it is more likely a complication related to the surgical procedure itself rather than the valve.It should be noted that the patient has a medical history of atrial fibrillation requiring dccv prior to the implant of the onxaap device.No further action is required.Based on the available information, a definitive root cause for this event cannot be determined.Additionally, without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.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 ASCENDING AORTIC 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: 15986517
• MDR Text Key: 305505880
• Report Number: 1649833-2022-00068
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 851788001525
• 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,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXAAP-23
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/17/2022
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male