MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC ANATOMIC 19; HEART-VALVE, MECHANICAL

Model Number ONXACE-19

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

Patient Problem Corneal Pannus (1447)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

According to the distributor, "onxace-19, being upside down, was used as mitral for mvr.Artificial graft 20mm was seated on annulus and 19mm valve was sewed to the graft.After the valve was implanted, the surgeon checked blood flow thru echography and found abnormal regurgitation from between inside orifice and leaflet when leaflet closed.To make sure of the regurgitation, he rotated the valve by 90 degree and found regurgitation rotated accordingly as well.Thus, he determined it was not pvl, but suspected leaflets dysfunction, replaced it with competitor¿s valve and operation was done successfully." this investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report, on-x aortic valve was explanted on (b)(6) 2020.

Manufacturer Narrative

Additional information received: date of surgery: (b)(6) 2020 (redo).Primary surgery: date unknown.[competitor] was implanted due to mvr before this surgery.Explanted valve: onxace-19 (conform x aortic valve) serial number (sn): (b)(6).Cause of the event: redo, due to pannus formation.Description of the event: onxace-19, being upside down, was used as mitral for mvr.Artificial graft 20mm was seated on annulus and 19mm valve was sewed to the graft.After the valve was implanted, the surgeon checked blood flow thru echography and found abnormal regurgitation from between inside orifice and leaflet when leaflet closed (see attached echographic movie).To make sure of the regurgitation, he rotated the valve by 90 degree and found regurgitation rotated accordingly as well.Thus, he determined it was not pvl, but suspected leaflets dysfunction, replaced it with competitor¿s valve and op was done successfully.Patient: 1.5-year-old female infant.No infection was detected.The explanted valve was returned to on-x life technologies, inc.For further evaluation.Prior to decontamination, visual examination of valve found no damage to the leaflets or housing.After decontamination, the sewing cuff was cut to expose the serial number on the housing and it was determined that the part was in fact the onxace-19 sn (b)(6).No damage was observed on the housing or leaflets.Leaflets move freely and the valve rotates as intended.The part passed all inspection.No root cause could be identified.The part was functioning as intended when returned for evaluation.The manufacturing records for onxace-19 sn (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.Onxace-19 sn (b)(6) appears to have been implanted and explanted on (b)(6) 2023.It was attempted to be used in the mitral position of a 1.5-year-old female patient by sewing in to a 20mm artificial graft placed on the annulus.Upon echocardiogram, the surgeon determined that the valve was abnormally regurgitant.After assessing it for the possibility of paravalvular leaking (pvl) by rotating the valve and observing that the same flow characteristics moved with the rotation, pvl was ruled out and the diagnosis was improper/inadequate closure of the leaflets.The on-x valve was successfully replaced with that of another manufacturer.From the information we have, it is uncertain whether this regurgitation is a consequence of structural valve dysfunction (leaflets did not move as expected due to the valve construction) or nonstructural valve dysfunction (leaflet interference due to external or anatomic factors).The valve was returned to the manufacturer for examination.Manufacturing records show a normal construction.Visual examination of the explant reports that ¿leaflets move freely and the valve rotates as intended¿ which would tend to rule out structural dysfunction.A third possibility is that the ¿abnormal¿ regurgitation may have been a misinterpretation of the normal washing jets for an on-x valve, whose hemodynamic ¿signature¿ is different from those of competitor valve with which the observer may be more familiar, and which would move with valve rotation.This is further supported, if not confirmed, by the surgeon¿s observation of the ¿abnormal regurgitation from between the inside orifice and leaflet when leaflet closed¿ which is exactly where and when the washing jets would appear.Consequently, with the information we have, it is uncertain whether the on-x valve actually failed, or was misinterpreted to fail.The instructions for use (ifu) for an on-x valve acknowledge the possibility or explantation as a consequence of a complication, but in this case, we are not assured the complication was real or interpreted as such.The event does not identify any additional hazards or modify the probability and severity of existing hazards.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 ANATOMIC 19
• 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: 10342128
• MDR Text Key: 202110892
• Report Number: 1649833-2020-00026
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXACE-19
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/01/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR