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 No Code Available (3191)

Event Date 06/11/2020

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 (serial number) (b)(4) was explanted on (b)(6) 2020 and replaced with an onxaap-27/29.

Event Description

According to the initial report, onxace-27/29 sn (serial number) (b)(6) was explanted on (b)(6) 2020 and replaced with an onxaap-27/29.

Manufacturer Narrative

Attempts to obtain additional information were made with no response.The manufacturing records for onxace-27/29 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.Onxace-27/29 sn (b)(6) was implanted (b)(6) 2016 in the aortic position of a 32-year-old male.It was replaced by an onxaap-25 aortic valved conduit on (b)(6) 2020 (3 years 299 days post-implant) in a double valve procedure with onx-32/33 implanted in the mitral position.No other information was made available.Reoperation and explantation are recognized risks associated with complications of prosthetic heart valves [ifu], but in this case we have no evidence to indicate what, if any, contribution the original on-x valve made to the decision for its removal.The event does not identify any additional hazards or modify the probability and severity of existing hazards.An on-x aortic valve was replaced with an on-x aortic valved conduit, but the reason for its removal is unknown.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: 10355919
• MDR Text Key: 202112419
• Report Number: 1649833-2020-00031
• 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
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

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: No Information
• Device Expiration Date: 07/01/2022
• Device Model Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/09/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR