MAUDE Adverse Event Report: ON-X LIFE TEHCNOLOGIES, INC. ON-X PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE

Model Number	ONXM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not evaluated because it was disposed of at the hospital and not returned.Manufacturing records reviewed and indicate the valve was built per specifications.
Event or Problem Description
During tracking database data entry, it was noted that the same patient had 2 mitral valve implants, 1 implanted on (b)(6) 2015, then another on (b)(6) 2015.Called hospital to find out what happened and found that the first valve had to be explanted because anatomic tissue loosened and interfered with the prosthetic valve functionality, resulting in the need to do a re-do mitral valve replacement.The following description comes from the surgeon's operative report: after removal of the mechanical valve, it was found that there were large sinus pouches at the posterior wall just below the posterior mitral annulus/fibrotic tissue that was attached to the mitral valve.These pouches were not seen during the last operation, which appeared covered by the mitral annulus/fibrotic tissue.The mitral annulus/fibrotic tissue was originally attached to the ventricular wall below the sinus pouches, which was probably detached suddenly from the ventricular wall last night, causing the malfunction of the prosthetic mitral valve.The patient had to be re-operated and a new on-x valve was implanted, this time a larger sewing ring model was chosen and it was seated higher in the left atrium.Patient was easily separated from cardio-pulmonary bypass, there were no complications.And was transferred to icu in stable condition.Factors requiring this to be reported are: patient had re-operation to re-do the mvr, re-op is classified as a serious injury, anatomical interference with leaflet motion required medical intervention to prevent permanent injury.For these reasons, this is reportable.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TEHCNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• MDR Report Key: 5457967
• Report Number: 1649833-2016-70007
• Device Sequence Number: 423873
• Product Code: DYE
• UDI-Device Identifier: 00851788001273
• UDI-Public: 00851788001273
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/29/2020
• Device Model Number: ONXM
• Device Catalogue Number: ONXM-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2016
• Initial Report FDA Received Date: 02/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 56