MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT (ONXA; HEART VALVE, MECHANICAL

Model Number ONXAAP-23

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

Patient Problem Atrial Flutter (1730)

Event Date 01/23/2012

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 notification , "patient is in the post-market clinical follow-up study protocol of the on-x ascending aortic prosthesis (aap) retrospective study and was implanted on (b)(6) 2011 with an aap device with an unknown sn.This subject experienced adverse event during the dates of data collection [implant to (b)(6) 2021 that were reported to the sponsor.Below is a summary of each event: on (b)(6) 2012 : diagnosis of atrial flutter with rvr with cardioversion on (b)(6) 2012 adjudicated as : probably valve related, probably procedure related and not anticoagulation related.Limited information was provided as this was a retrospective study, all available information will be submitted with this report." this complaint investigation is relegated to the on 23jan2012 event for onxaap-23, sn (b)(6).

Manufacturer Narrative

According to the initial notification "patient is in the post-market clinical follow-up study protocol of the on-x ascending aortic prosthesis (aap) retrospective study and was implanted on (b)(6) 2011 with an aap device with an unknown sn.This subject experienced two adverse events during the dates of data collection [implant to (b)(6) 2021] that were reported to the sponsor.Below is a summary of each event: (b)(6) 2011 : diagnosis of heart block adjudicated as : probably valve related, probably procedure related and not anticoagulation related.(b)(6) 2012 : diagnosis of atrial flutter with rvr with cardioversion on (b)(6) 2012 adjudicated as : probably valve related, probably procedure related and not anticoagulation related.Limited information was provided as this was a retrospective study, all available information will be submitted with this report." this complaint investigation is relegated to the (b)(6) 2012 event for (b)(4), sn (b)(6).The manufacturing records for (b)(4) 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.During the investigation no non-conformances or deviations were noted.Document change orders were issued for leaflet tuning as a part of the standard manufacturing process.The available information was reviewed.An (b)(4) device with sn (b)(6) was implanted on (b)(6) 2011 with concomitant procedures of an hemiarch replacement with resection of ascending aortic aneurysm, mitral valve repair with annuloplasty and cabg in a 45 year old female whose records were retrospectively acquired for a post-market study: (b)(4) (11/20)- post market clinical follow up study protocol of the on-x ascending aortic prosthesis (aap)- single site retrospective study.This event refers to study patient number (b)(6).One day post implant on (b)(6) 2011 the patient was diagnosed with heart block.And then on (b)(6) 2012 (33 days post implant) the patient was diagnosed with atrial flutter with rvr and underwent cardioversion.No source documents are available for review and no other interventions or follow up notes are available.The events were adjudicated as probably valve related and probably procedure related.The instructions for use [ifu] for the aap valve lists 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.It is reported here only for the purpose of consistency in documenting potential adverse events made known to the manufacturer and does not qualify for comparison to the historical record of valve performance.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.No further action is required without additional information.A review of the information was performed to compile a risk analysis.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.The patient was enrolled in a post-market clinical follow-up study; thus, severity and occurrence is not evaluated.No further action is required without additional information.With the limited information provided a root cause for the event cannot be determined; however, cardiac arrhythmia is recognized as a potential adverse event in the ifu and the device history record review found the device to meet release specification.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.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.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT (ONXA
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; building b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; building b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18640865
• MDR Text Key: 334554275
• Report Number: 1649833-2024-00019
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening