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

Model Number ONXAE-23

Device Problem Obstruction of Flow (2423)

Patient Problem Occlusion (1984)

Event Date 06/24/2020

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, the implant registration card for onxae-23, sn (b)(4) had "explanted" written on it.After review of the patient's file, the hospital nurse confirmed the valve was explanted due to a concern that the on-x valve was occluding the left coronary artery or stretching the patient's annulus.Additional information was provided by the cryolife representative, "the valve was explanted because the surgeon could not spin the valve after the sutures were in.The high points of the valve were blocking the coronaries per the surgeon.".

Manufacturer Narrative

A review was performed by clinical/medical of the available information.Onxae-23 sn (b)(6) was implanted (b)(6) 2020 in the aortic position.It was reported the valve was explanted the same day as its implantation.The surgeon¿s nurse noted, ¿surgeon concerned valve was occluding left coronary or stretching annulus which was impeding flow down left main coronary artery.¿ a cryolife representative also noted "this valve was explanted because the surgeon could not spin the valve after the sutures were in.The high points of the valve were blocking the coronaries per the surgeon.¿ it is known that the valve was replaced with one from another manufacturer and that the patient was doing well after discharge; however, the specific model and manufacturer are unknown.The information provided reflects the surgeon's concern that the inflow to the left coronary artery would be obstructed.Whether this is a consequence of valve placement, i.E.Surgical technique.Or potential patient anatomy (coronaries lower than is typical) is indeterminate.There is no indication that the on-x was ever operational or failed to function as designed.The instructions for use [ifu] for the on-x valve acknowledge explantation as a potential consequence of a complication following prosthetic valve replacement.The complication in this case is related to valve placement in conjunction with patient anatomy.The likely cause of potential obstruction of the left coronary artery is the placement of the valve, though patient anatomy may have played a role, too.There is no indication that the valve itself failed to function as designed.No further action is required without additional information.Risk performed a review of the available information.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.The root cause of this event is unknown.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 STANDARD 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: 10346333
• MDR Text Key: 202111185
• Report Number: 1649833-2020-00027
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001402
• UDI-Public: 00851788001402
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/23/2021
• Device Model Number: ONXAE-23
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 08/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other