MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number ONXM-27/29

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/26/2020

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 by the device tracking team, "'explanted' written on irc.Replaced with sn (b)(4) onxm 27/29".The cryolife representative relayed the following information: "onxm 27/29 sn for explanted valve is (b)(4) exp.4-14-2026.The procedure was mitral valve replacement w 27/29 onx valve tricuspid valve repair w/annuloplasty ring and sternal plating system.[the surgeon] has the actual valve, i will see if he can return it.I am being told a leaflet was malfunctioning.".

Manufacturer Narrative

Clinical/medical performed a review of the available information.Onxm-27/29 sn (b)(6) was implanted in the mitral position of a (b)(6) female patient on (b)(6) 2020.The valve was explanted and replaced the same day with another on-x mitral valve of the same model and size, onxm-27/29 sn (b)(6).This event was announced by a handwritten note of "explanted on the implant registration card for sn (b)(6).According to the local cryolife cardiovascular specialist "tricuspid valve repair with annuloplasty ring and sternal plating system was performed.The representative was also told concerning the explanted valve that "a leaflet was malfunctioning· and would look into the return to cryolife of the explanted device.To date, the explanted valve has not been returned to the manufacturer for further analysis and no other information was provided to explain this replacement.Consequently, we do not have enough information to know what, if any, contribution the valve has to the leaflet malfunction.The instructions for use for the on-x valve lists the possibility of reoperation and/or explantation as a consequence of a complication of prosthetic heart valve replacement [ifu].In this instance, the complication is presumed to be prosthetic valve dysfunction, but we do not know if the valve malfunctioned (structural dysfunction) or if there was some anatomic or other interference (non-structural dysfunction) with its movement.Root cause is prosthetic valve dysfunction, but there is not enough information to determine for certain what, if any, contribution the on-x valve had to that diagnosis.No further action is required without additional information.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 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 for this event is prosthetic valve dysfunction, but there is not enough information to determine for certain what, if any, contribution the on-x valve had to that 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.

Event Description

The valve will not be returned for evaluation.

• Brand Name: ONX MITRAL STANDARD 27/29
• 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: 10351384
• MDR Text Key: 202111456
• Report Number: 1649833-2020-00028
• 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: 09/11/2020

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 Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other