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

Model Number ONXAAP-23

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

Patient Problems Endocarditis (1834); No Code Available (3191)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

A hospital report was received indicating this valve [onxaap-23 sn (b)(4)] was explanted.

Event Description

Additional information received on 15-may-2020 after phone call with the surgeon's medical secretary.The following questions were answered: why was onxaap-23 explanted? patient had endocarditis.Was there a deficiency with the valve? there was no deficiency.Was it replaced with another on-x valve? if so, can we have model size and serial #? if not, was it replaced with another manufacturer¿s valve? replaced with another manufacturer's valve.Is a copy of the operative notes available for us to have? no, not without patient permission.How is the patient post-operatively? fine.

Manufacturer Narrative

A review was performed by clinical/medical of the available information.An onxaap-23 sn (b)(6) was implanted (b)(6) 2019 in a 16-year-old.It was reported as explanted on (b)(6) 2020 (273 days post-implant).Correspondence with the surgeon's office indicated the reason for the explant was due to endocarditis (infection) and that there was no valve deficiency.The patient was also reported to be doing "fine." endocarditis (infection) typically causes deterioration of the annular tissue resulting in loss of attachment (dehiscence) of a prosthetic valve to the adjoining tissue.This particular on-x device was replaced by that from another manufacturer (not identified).The operative report of the explantation surgery was not available for review.Of note, it is unlikely the on-x valve was the source of the infection as on-x valves undergo a validated terminal sterilization process during manufacturing.The instructions for use [ifu] for the on-x valve acknowledge endocarditis as a risk factor in prosthetic valve replacement which may result in reoperation and explantation.The historical record shows an occurrence rate of 1.2 %/patient-year for endocarditis for recipients of rigid heart valve substitutes [iso 5840:2005].There is no evidence that the on-x valve had any relation to the diagnosis and decision requiring its eventual removal.Endocarditis is the underlying cause of the explantation and replacement of the on-x prosthesis.No further action is required.Risk performed a review of the available information.The on-x ascending aortic prosthesis (aap) risk management file thoroughly identifies the process and product hazards for approved indications.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.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.The root cause was endocarditis.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 ASCENDING AORTIC 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: 10051623
• MDR Text Key: 191405495
• Report Number: 1649833-2020-00015
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/01/2022
• Device Model Number: ONXAAP-23
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 16 YR