MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES ONX AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL

Model Number ONXACE-21

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

Patient Problem Endocarditis (1834)

Event Date 09/10/2020

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 implant registration cards received, "received an aortic and mitral implant registrations (sn (b)(4) onxace 21; sn (b)(4) onxm 27/29) for patient already with aortic and mitral implants." this investigation will be relegated to onxace-21, sn (b)(4).The surgeon stated, "this most likely was the endocarditis case.Placed them for endocarditis and then patient came back 6 months later with recurrent disease and had to re replace." the valve will not be returned.No additional information forthcoming.

Manufacturer Narrative

Clinical/medical performed a review of the available information.An onxace-21 sn (b)(6) and onxm-31/33 sn (b)(6) were implanted (b)(6) 2020 in the aortic and mitral positions.Respectively, of a 34-year-old male.On 2020 sep 10 (210 days post-implant) both valves were explanted and replaced by an onxace-21 sn (b)(6) and onxm 27/29 sn (b)(6) in the aortic and mitral positions, respectively.A note from the surgeon states: "this most likely was the endocarditis case.Placed them for endocarditis and then the patient came back 6 months later with recurrent disease and had to replace." with reference to the onxace-21 sn (b)(6), it is unlikely that the on-x valve was a source of the infection as on-x valves undergo a validated terminal sterilization process during manufacturing.While the source of the infection remains unknown, there is no indication that the valve failed to function as designed but more probable that the infection had caused tissue annulus deterioration thereby compromising the anchoring sutures and attachment of the device.Endocarditis is a known risk factor of prosthetic valve replacement with a potential for reoperation and explantation [ifu].The historical record shows an occurrence rate of 1.2 %/patient-year for endocarditis for recipients of rigid heart valve substitutes [iso 5840:2005].Endocarditis is the underlying cause of the explantation and replacement of the on-x prosthesis.There is no evidence that the on-x valve contributed to the genesis of infection nor that it failed to perform as designed.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.A comprehensive study will be conducted to determine if changes are required to the hv risk management file with emphasis on hv dfmea occurrence rate for endocarditis.The root cause for this event is endocarditis; however, there is no evidence to suggest the on-x valve contributed to this event.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 CONFORM EXT 21
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg . b; austin TX 78752
• MDR Report Key: 10935902
• MDR Text Key: 219315133
• Report Number: 1649833-2020-00047
• 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
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/08/2023
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other