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

Model Number	ONXACE
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	12/27/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"serious injury" is only applicable choice as the patient had to endure a re-operation.The issue was actually an adverse event.Valve was disposed of at hospital and is not available for return for investigation.Review of device history records shows the valve was built per specifications.There will not be a follow-up report.
Event or Problem Description
While entering tracking system data, an explant report was encountered.Reason for explant was researched and found to be due to paravalvular leak (pvl), 2 years post-op.Re-operated and replaced with a tissue valve.Minimally invasive surgical technique was used.Patient presented at hospital with progressive worsening shortness of breath, chest pain.Aortic insufficiency.This is aortic valve replacement (avr) #3 for this patient.First valve was tissue in 2008, 2nd was on-x in 2013, latest re-do was another tissue valve.1st avr failed due to endocarditis.Received extensive medical records and op notes for this patient this is being reported because pvl is defined in the aats/sts guidelines as valve-related and reportable.It is listed among the adverse events that can occur for a heart valve patient, in section 5 of the ifu.This event is occuring within expected frequency and no trends are seen.

• 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: 5516084
• Report Number: 1649833-2016-70015
• Device Sequence Number: 1037491
• Product Code: DYE
• UDI-Device Identifier: 00851788001471
• UDI-Public: 00851788001471
• 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: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/16/2018
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2016
• Initial Report FDA Received Date: 03/22/2016
• 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: 64 YR