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

Model Number ONXAAP-27/29

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

Patient Problem Aneurysm (1708)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to implant registration cards returned from the hospital, onxaap-27/29, (b)(4), implanted (b)(6) 2018, explanted (b)(4) 2018 and replaced with onxaap-27/29, (b)(4).Additional information received: patient had bentall, ascending and full arch for type a dissection and came back for root false aneurysm due to infection and had to have his root done again.This is totally unrelated to the valve as it was functioning well.No evidence of endocarditis.

Manufacturer Narrative

The manufacturing records for the onxaap-27/29 sn: (b)(4) 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.Onxaap- 27/29 sn: (b)(4) was implanted on (b)(6) 2018 in the aortic position of a 54 year old male and replaced on (b)(6) 2018 (245 days post-implant) with another onxaap-27/29 sn: (b)(4), as observed in the manufacturer 's device tracking database.Follow-up information from the field received january 11, 2019: "pt had bentall, ascending and full arch for type a dissection in august 2018 and came back for root false aneurysm due to infection and had to have his root done again.This is totally unrelated to the valve as it was functioning well.No evidence of endocarditis.¿ the report from the field serves to identify the reason for explant to be due to a false aneurysm as a result of infection, but without evidence of endocarditis.The aortic root, apart from the valve which was functioning normally, required reconstruction/replacement.There is no evidence that the valve contributed to the need for replacement.Nevertheless, the instructions for use [ifu] note that reoperation and explantation of the prosthetic valve are risks associated with a complication.The ifu also lists false aneurysm as a potential adverse event, which, in this case, precipitated the reoperation.The development of a false aneurysm requiring restoration of the aortic root necessitated the replacement of the on-x ascending aortic prosthesis.There is no evidence that the on-x valve contributed to the cause of the adverse event.No further action is required.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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to implant registration cards returned from the hospital, onxaap-27/29 serial number: (b)(4) implanted on (b)(6) 2018, explanted on (b)(6) 2018 and replaced with onxaap-27/29 sn: (b)(4).Additional information received: patient had bentall, ascending and full arch for type a dissection and came back for root false aneurysm due to infection and had to have his root done again.This is totally unrelated to the valve as it was functioning well.No evidence of endocarditis.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8242037
• MDR Text Key: 132913501
• Report Number: 1649833-2019-00001
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXAAP-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/03/2019
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 54 YR