MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficiency, Valvular (1926); Mitral Valve Stenosis (1965); Cardiac Tamponade (2226); Foreign Body In Patient (2687)

Event Date 08/28/2019

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 initial reports, the patient was implanted with onxmc-25/33 on (b)(6) 2018 for mitral stenosis.The patient was admitted to the hospital on (b)(6) 2019 where dysfunction of the valve was detected by ultrasound.The patient underwent operation on (b)(6) 2019 where it was found that one lid of the valve was missing.A defective flap was removed and a new flap was sewn in.Further diagnostics showed the missing lid in the pelvis.The patient will undergo operation to have this removed.Additionally, another fragment of the valve was missing and found in the wall of the main artery in the chest.The patient is expected to survive without complications besides the metal fragment in the aorta which, due to the risk, has not been removed.

Manufacturer Narrative

The patient was implanted with onxmc-25/33 on (b)(6) 2018 for mitral stenosis.After the implant operation, the patient had post-operative bleeding and the staff had to stop the bleeding, but the valve was not affected during this post-procedure.The patient was re-operated pericardial blood was evacuated.An echocardiograph was performed afterward and indicated a well-functioning valve without any bleeding.The patient was re-admitted to the hospital on (b)(6) 2019 where dysfunction of the valve was detected by ultrasound.The patient underwent operation on (b)(6) 2019 where it was found that the valve leaflet was broken.One major part of the leaflet was found in an artery near the pelvis.This piece was successfully removed.Additionally, another fragment of the valve was missing and found in the wall of the main artery in the chest.The patient is expected to survive without complications besides the metal fragment in the aorta which, due to the risk, has not been removed.A sample evaluation and a scanning electron microscope (sem) examination were performed.Prior to decontamination, visual examination of the valve found the housing fractured into two pieces.A fragment from the housing was also received.One leaflet was still contained within the housing, but the other was removed and broken (the broken fragment was not returned).After decontamination, visual examination noted a chip along the outflow rim.The remaining leaflet articulated normally and the sewing cuff fit to the housing appeared normal.The fractures appear to be caused by direct contact with an instrument.Sem scans of the part found iron and chromium elements which are common in surgical steel used in instrumentation.The fracture on the housing appears to be related to manipulation with metallic instrument.If a metal instrument was used during implantation, it could have caused damage to the leaflet that led to the eventual fracture of the leaflet.Manipulating the leaflets with a metal instrument during implantation could lead to a substrate fracture that would not be detectable with the naked eye.Continuous use of the valve could lead to a total fracture with time.The location of the fracture on the leaflet could have contributed to the dissociation of the leaflet from the housing.The manufacturing records 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.Precise method of leaflet fracture cannot be determined based on the available evidence.It is possible that blunt trauma induced by exercise or metallic contact during implant resulted in the initial fracture but this cannot be verified.Therefore, it is not certain whether the on-x valve is the instigator or the recipient of circumstances leading to failure.The classification of this event is that of prosthesis structural dysfunction with consequent reoperation and explantation.All of these are recognized in the instructions for use as possible adverse events associated with prosthetic valve replacement.The precise method of leaflet fracture and escape cannot be determined based on the available information.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.

Manufacturer Narrative

Corrected data: b3/b4/b5/b6: description updated.Relevant tests added.B7: other relevant history added.D4: serial number added.D6/d7/d8: implant date updated.Explant date added.H3.Device return questions updated.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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 patient was implanted with onxmc-25/33 on (b)(6) 2018 for mitral stenosis.After the implant operation, the patient had post-operative bleeding and the staff had to stop the bleeding, but the valve was not affected during this post-procedure.An echocardiograph was performed afterward and indicated a well-functioning valve without any bleeding.The patient was admitted to the hospital on (b)(6) 2019 where disfunction of the valve was detected by ultrasound.The patient underwent operation on (b)(6) 2019 where it was found that the valve lid was broken.One major part of the lid was found in an artery near the pelvis.This piece was successfully removed.Additionally, another fragment of the valve was missing and found in the wall of the main artery in the chest.The patient is expected to survive without complications besides the metal fragment in the aorta which, due to the risk, has not been removed.

• Brand Name: ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING
• 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: 8976098
• MDR Text Key: 161339184
• Report Number: 1649833-2019-00052
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention