MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 27/29; HEART-VALVE, MECHANICAL

Model Number ONXACE-27/29

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

Patient Problem Endocarditis (1834)

Event Date 02/04/2020

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 the initial report, onxace-27/29 sn 5403810 was implanted on (b)(6) 2018, and replaced with an onxaap-27/29 on (b)(6) 2020.Additional information received stated, "[patient] had prosthetic aortic valve endocarditis/dehiscence of the aortic valve prosthesis with rocking of the valve, an aortic root abscess, and mitral valve endocarditis.Procedure was mvr and bentall procedure with 29-mm bileaflet on-x mechanical conduit.".

Manufacturer Narrative

The manufacturing records for serial number (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.According to an implant registration card (irc), an onxace-27/29 sn (b)(6) was implanted (b)(6) 2018 in a 39-year-old male.On (b)(6) 2020 (1 year 125 days post implant) another irc indicated onxaap-27/29 sn (b)(6) was reported as implanted in the aortic position of the same patient.Subsequent information requested of the institution indicated that the onxace-27/29 had been explanted due to ¿prosthetic aortic valve endocarditis/dehiscence of the aortic valve prosthesis with rocking of the valve, an aortic root abscess, and mitral valve endocarditis.¿ endocarditis (infection) causes deterioration of the annular tissue resulting in loss of attachment (dehiscence) of a prosthetic valve to the adjoining tissue.Observed here as ¿rocking of the valve¿ the tissue in the region was in such bad shape that not only was the on-x valve replaced, but it was replaced by a valved conduit (onxaap) as well as a mitral valve replacement (mvr, model not specified).Of note, it is unlikely the on-x valve was the source of the infection as on-x valves undergo a validated terminal sterilization process during manufacturing.The institution has not heard from or about the patient since his release from a rehabilitation facility on (b)(6) 2020.The instructions for use (ifu) for the on-x valve acknowledge endocarditis as a risk factor in prosthetic valve replacement which may result in reoperation and explantation.The historical records shows an occurrence rate of 1.2 %/patient-year for endocarditis for recipients of rigid heart valve substitutes [iso 5840:2005].There is no indication that the original on-x valve failed to function as designed, only that it became detached from its anchoring tissue.This event does not identify additional hazards or modify the probability and severity of existing hazards.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: ONX AORTIC CONFORM EXT 27/29
• 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: 9953352
• MDR Text Key: 191404845
• Report Number: 1649833-2020-00009
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001488
• UDI-Public: 00851788001488
• 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
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/16/2020
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR