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-23

Device Problem Insufficient Information (3190)

Patient Problems Regurgitation, Valvular (2335); Pseudoaneurysm (2605)

Event Date 07/08/2019

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, patient received onxaap-23, sn (b)(4), (b)(6) 2016.The same patient received onxaap-25, sn (b)(4), (b)(6) 2019.This investigation will be relegated to the onxaap-23, sn (b)(4).Additional information received from surgeon's office.Severe mitral and tricuspid regurgitation, pseudoaneurysm, annulus debrided, aortic dissection.Current status of the patient unknown.According to the patient's chart, there was nothing noted regarding prosthetic valve deficiency.

Event Description

According to implant registration cards, patient received onxaap-23 sn (b)(6) on (b)(6) 2016.The same patient received onxaap- 25 sn (b)(6) on (b)(6) 2019.This investigation will be relegated to the onxaap-23 sn (b)(6).Additional information received from surgeon's office.Severe mitral and tricuspid regurgitation, pseudoaneurysm, annulus debrided, aortic dissection.Current status of the patient unknown.According to the patient's chart, there was nothing noted regarding prosthetic valve deficiency.

Manufacturer Narrative

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 sn (b)(6) was implanted in a 56-year-old male patient in the aortic position on (b)(6) 2016 which was explanted and replaced with a valved conduit onxaap-25 sn (b)(6) on (b)(6) 2019 (3 years 4 days post-implant).Information from the surgeon's office on september 9, 2019 states: severe mitral and tricuspid regurgitation, pseudoaneurysm (location not specified), annulus debrided, aortic dissection.Current state of the patient unknown.Were we to know the location of the pseudoaneurysm we might be able to get a better idea of what the problem is.The patient began with an on-x valved conduit which was replaced with another on-x valved conduit, slightly larger, and coupled with the observation of severe mitral and tricuspid regurgitation suggests there are significant cardiac abnormalities present.But the only operation we know about is the valve replacement about which we do not have enough information to determine what, if any, relationship the need to replace the first aap with the second is the result of a valve dysfunction or only part of the solution to a bigger, more complex problem.False aneurysm (pseudoaneurysm) is identified as a potential adverse event in the instructions for use of the onxaap, a consequence of which reoperation and/or explantation may be necessary [ifu].Based on the available information, a definitive root cause for this event cannot be determined.Furthermore, there is no suggestion, evidence, or indication that the valve was functionally deficient except that the patient's condition warranted the placement.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 cryolife and the ifu adequately communicates risk.No further action is warranted at this time.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.

• 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: 9050329
• MDR Text Key: 161976347
• Report Number: 1649833-2019-00055
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2020
• Device Model Number: ONXAAP-23
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/09/2019
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR