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

Model Number ONXANE-23

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

Patient Problem Endocarditis (1834)

Event Date 07/28/2020

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 received, "patient is participant #410 in the on-x aortic post approval study (pas).Adverse event is endocarditis attributed to strep oralis." this investigation will be relegated to onxane-23, sn (b)(4).Adjudicator review states, "prosthetic valve endocarditis under treatment.Adjudication form will be faxed after 9/3/2020".

Manufacturer Narrative

Clinical/medical performed a review of the available information.Onxane-23 sn (b)(6) was implanted (b)(6) 2019 in the aortic position of a [patient].On (b)(6) 2020 (361 days post implant) the patient was diagnosed with endocarditis (infection).To date, the patient has been hospitalized and treated with medication; the valve is still in place.The instructions for use [ifu] for the on-x valve acknowledge endocarditis as a risk factor in prosthetic valve replacement.Because all on-x valves undergo a validated terminal sterilization process during manufacture, and because it has been almost a year since implantation, it is unlikely that the valve is the source of the endocarditis.The historical record shows an (b)(4) for endocarditis for recipients of rigid heart valve substitutes [iso 5840:2005].There is no indication that the on-x valve has failed to function as designed.Endocarditis is the root cause of the complaint.There is no indication that the on-x valve contributed in any way to the diagnosis.Should additional information become available, it will be reviewed and a need for investigation will be determined then.Risk management reviewed the available information.The on-x heart valve risk management file thoroughly identifies the process and product hazards for indication.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.The root cause for this event is endocarditis; however, there is no indication the on-x valve contributed to this diagnosis.There is no indication that an error or deficiency occurred at cryolife and all risks identified have been mitigated as far as possible and residual risk is acceptable.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 ANATOMIC 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: 10600412
• MDR Text Key: 208975371
• Report Number: 1649833-2020-00041
• 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: study
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXANE-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other