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

Model Number ONXM-27/29

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

Patient Problems Death (1802); Rupture (2208)

Event Date 08/20/2018

Event Type  Death  

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, "routine mitral valve replacement up to closure at which point patient suffered ventricular rupture.Valve was removed, attempted repair to ventricle, st.Jude valve implanted, patient placed on ecmo [extracorporeal membrane oxygenation].Patient died shortly after.".

Manufacturer Narrative

The manufacturing records for the onxm-27/29 sn (b)(4) 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.A review of the available information was performed.Onxm-27/29 sn (b)(4) was implanted on (b)(6) 2018 in a female patient with a rheumatic mitral valve.It was routine mitral surgery until closure when the patient's heart muscle tissue failed (ventricular rupture).The on-x valve was explanted during the attempt to repair the rupture and a st.Jude implanted instead.However, the patient did not recover well and was placed on extracorporeal membrane oxygenation (ecmo), which is used to facilitate oxygenation of the blood while the compromised heart tries to heal.Unfortunately, the patient did not survive the experience and died "shortly after." a subsequent report from the surgeon goes into much greater detail and warrants extensive quoting: ¿the post-op toe [transesophageal echocardiogram] on coming of bypass showed the valve was well seated with no stenosis or regurgitation or paravalvular leak and no aneurysm.As i was closing the chest there was a sudden unheralded ventricular rupture at the posterior annulus with massive bleeding and arrest.Despite going back on bypass and doing an extensive patch repair of the posterior rupture and placing a smaller st jude mitral valve, we had significant bleeding from the posterior left ventricle and i had to place the patient on ecmo to control the bleeding.6 days later she failed to wean off ecmo and had thrombosed the mitral valve and left ventricle so we withdrew care.On reviewing the literature the risk factors for rupture would be where the posterior mitral leaflet has to be removed and the annulus decalcified and the prosthetic valve is then impinging on the posterior left ventricular wall and probably with ventricular contraction a rupture then occurs.She was an older lady with probably a thinner walled ventricle also.¿ this is a failure of the ventricle of the heart, which physically tore and could be considered a form of heart failure simply because the heart was no longer able to pump as it should.Many factors contributed to this outcome, but all point to a weakened heart tissue as a result of disease, age, and surgical intervention.The on-x valve was removed while the tear was repaired and a new valve (st.Jude) implanted in its stead.Ventricular rupture during surgery is the primary contributor leading to the need for explantation and replacement of the just-implanted on-x mitral prosthetic heart valve.There is no indication that the on-x valve failed to function as expected.The instructions for use for the on-x valve lists heart failure and prosthesis nonstructural dysfunction as possible complications of mechanical heart valve replacement and includes the possibility of explantation and death.A prediction of operative mortality for a mitral valve replacement, as described in the journal of the american college of cardiology, is 6.04% [edwards 2001].

Event Description

According to the initial report, "routine mitral valve replacement up to closure at which point patient suffered ventricular rupture.Valve was removed, attempted repair to ventricle, st.Jude valve implanted, patient placed on ecmo [extracorporeal membrane oxygenation].Patient died shortly after." additional information from the surgeon's report: "the post-op toe [transesophageal echocardiogram] on coming of bypass showed the valve was well seated with no stenosis or regurgitation or paravalvular leak and no aneurysm.As i was closing the chest there was a sudden unheralded ventricular rupture at the posterior annulus with massive bleeding and arrest.Despite going back on bypass and doing an extensive patch repair of the posterior rupture and placing a smaller st jude mitral valve, we had significant bleeding from the posterior left ventricle and i had to place the patient on ecmo to control the bleeding.6 days later she failed to wean off ecmo and had thrombosed the mitral valve and left ventricle so we withdrew care.On reviewing the literature the risk factors for rupture would be where the posterior mitral leaflet has to be removed and the annulus decalcified and the prosthetic valve is then impinging on the posterior left ventricular wall and probably with ventricular contraction a rupture then occurs.She was an older lady with probably a thinner walled ventricle also.¿.

• Brand Name: ONX MITRAL STANDARD 27/29
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg. b; austin; texas TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 7918590
• MDR Text Key: 122031466
• Report Number: 1649833-2018-00152
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/03/2018
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 09/03/2018
• Supplement Dates FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death