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

Model Number ONXACE-21

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

Patient Problems Aortic Insufficiency (1715); No Code Available (3191)

Event Date 03/20/2020

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 via email on (b)(6) 2020 from a cryolife representative relayed that onxace 21 malfunction.03/31/2020: additional information received via email from cryolife representative.After implanting, the gradients were greater than 60mm/hg.The surgeon feels that it [onxace21] was canted (one side raised up).He feels that it was a valve issue.04/07/2020: additional information received from the hospital's clinical coordinator,.The following was confirmed: the device was implanted on (b)(6) 2020 and explanted on (b)(6) 2020.The aortic valve replacement surgery was performed due to aortic insufficiency.The clinical coordinator also confirmed with the director of him (health information management) that operative notes will not be provided.

Manufacturer Narrative

A review was performed by clinical/medical of the available information.Onxace-21, sn (b)(6) was implanted in the aortic position of a patient on (b)(6) 2020.However, on (b)(6) 2020 (1-day post-implant) this prosthetic valve was explanted due to aortic insufficiency.The initial report was received via e-mails on 26-mar-2020 and 31-mar-2020 from a cryolife, inc.Representative who relayed that, ¿after implantation, the gradients were greater than 60 mm/hg.The surgeon feels that it [onxace-21] was canted (one side raised up).He feels that it was a valve issue·.It was later confirmed by the hospital's clinical coordinator that the aortic valve replacement surgery was performed due to aortic insufficiency.The clinical coordinator also confirmed with the director of health information management that operative notes will not be provided.With the surgeon's observation that the valve appeared ¿canted", it is probable that the cause could be due to the implanting technique.Because the flared portion of the on-x aortic valve sits inside the annulus, if one begins tying sutures at one spot and works their way around circumferentially, the valve can become canted (tilted) with the last portion protruding from the annulus.This sequence of stitching can constrict the annulus diameter, making it smaller with each stitch.Consequently, the valve can be left canted with an imperfect seal or unable to open and close efficiently with respect to the blood flow.Per the evaluation noted upon inspection of the explanted valve at cryolife austin facility, the part passed all inspections and met all requirements and specifications.No information was provided concerning the status of the patient after the explantation.The instructions for use [ifu] for the on-x valve acknowledge reoperation and explantation as potential consequences of a complication following prosthetic valve replacement but we have no evidence of any valvular malfunction.Aortic insufficiency was the reason behind the decision to explant the on-x mechanical heart valve prosthesis.It is possible that the valve had not been properly seated upon implantation.There is no evidence to suggest that the valve malfunctioned.No further action is required.Risk performed a review of the available information.A review of the returned valve found no deficiencies.The part still functioned as intended and met specification.The review of the device history record (dhr) found that the valve met all specifications and testing requirements.There were no issues found in the manufacture of the device.The clinical medical report states cause for explantation as: "aortic insufficiency was the reason behind the decision to explant the on-x mechanical heart valve prosthesis.It is possible that the valve had not been properly seated upon implantation.There is no evidence to suggest that the valve malfunctioned." the ifu provides instruction about the properly seating the valve in 9.5 suture techniques that states: "when all the sutures are in place, the valve is advanced into the annulus and the sutures are tied down.For aortic valves, it is suggested that the first 3 knots be tied equidistant to one another and midway between the commissures to stabilize the valve in the annulus." the on-x heart valve design fmea covers this : "improper instructions for implant and follow up/improper installation of valve of damage to valve/suture guidelines not followed".The on-x heart valve 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 further action is required.The root cause was aortic insufficiency.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, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9943424
• MDR Text Key: 191404651
• Report Number: 1649833-2020-00008
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other