MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. AORTIC HEART VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXACE-23

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

Patient Problem Death (1802)

Event Type  Death  

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, there was a post-operative death.

Event Description

According to the initial report, there was a post-operative death.

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxace-23 sn [serial number] (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.Additional information received indicated that the patient (dob (b)(6) 1952) was implanted with an onxace-23, sn (b)(4) on (b)(6) 2018.The only other information available was that the patient had endocarditis.A definitive cause for the patient death cannot be determined based on the limited available information, however, it is likely related to sequelae of endocarditis and the trauma of surgery.The instructions for use [ifu] for the on-x valve lists endocarditis as a possible complication of mechanical heart valve replacement and includes the possibility of reoperation and/or explantation and death.Historically, endocarditis occurs at a rate of 1.2%patient-year for rigid heart valves [iso 5840:2005].A definitive cause for the patient death cannot be determined based on the limited available information.There is no indication that the on-x valve had any relationship to the patient death.This event does not identify additional hazards or modify the probability and severity of existing hazards.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.

• Brand Name: AORTIC HEART VALVE WITH CONFORM-X SEWING RING
• 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: 8184282
• MDR Text Key: 130999958
• Report Number: 1649833-2018-00178
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/21/2018
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR