MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXACE-23

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

Patient Problem No Information (3190)

Event Date 07/03/2017

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 (irc) received, (b)(6) male patient implanted with onxace-23 (sn (b)(4)) on (b)(6) 2015 and required explant on (b)(6) 2017 due to unknown reasons and subsequent replacement via onxace-21.

Event Description

According to implant registration cards (irc) received, (b)(6) male patient implanted with onxace-23 (sn (b)(4)) on (b)(6) 2015 and required explant on (b)(6) 2017 due to unknown reasons and subsequent replacement via onxace-21.

Manufacturer Narrative

Multiple attempts were made to obtain additional information; however, all attempts were unsuccessful.The manufacturing records for the onxace-23 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.A review of the available information was reviewed.The on-x valve, onxace-23 sn (b)(4), was implanted (b)(6) 2015 in the aortic position, explanted and replaced by onxace-21 sn (b)(4) on (b)(6) 2017 (2 years 106 days post-implant).This information was noted from the implant registration cards since the patient and position were the same for both.The instructions for use acknowledge reoperation and explantation following a complication as risks of aortic valve replacement surgery.However, we have no other clinical evidence of any sort to evaluate, so we cannot tell what, if any, contribution the valve had to the need for the implant/explant procedure.Based on the limited information for this event, the root cause is unknown.No further action is required at this time without additional information.Adverse events are recognized and stated in the ifu.See the following excerpt.5.Potential adverse events - adverse events potentially associated with the use of prosthetic heart valves (in alphabetical order) include, but are not limited to: angina, cardiac arrhythmia, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, myocardial infarction, prosthesis leaflet entrapment (impingement), prosthesis nonstructural dysfunction, prosthesis pannus, prosthesis perivalvular leak, prosthesis regurgitation, prosthesis structural dysfunction, prosthesis thrombosis, stroke, thromboembolism, it is possible the these complications could lead to: reoperation, explantation, permanent disability, death.Root cause for this event is unknown.No action necessary.

• Brand Name: ONX AORTIC CONFORM EXT 23
• 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: 7045025
• MDR Text Key: 92510877
• Report Number: 1649833-2017-00085
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/25/2017
• Date Manufacturer Received: 10/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR