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 Codes	Aortic Insufficiency (1715); Congestive Heart Failure (1783)
Date of Event	05/13/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"serious injury" selected because patient had to go through a re-operation to correct the adverse event (endocarditis).Valve had been discarded by the hospital and is not available for investigation.Device history records for this valve were reviewed and found that the valve was built per specifications.
Event or Problem Description
This re-operation was observed when reviewing implant registration information in the tracking system database.On-x investigated and obtained the operative report for the re-operation.Per the op report, the patient had endocarditis (severe aortic insufficiency and paravalvular leak, secondary to endocarditis), 5 days post-operatively.The valve had dehisced (from sewing ring-to-tissue connection).Acute congestive heart failure, and acquired coagulopathy.Re-do aortic valve replacement (avr) was performed with an onxace-23 , s/n (b)(4).Post-op, patient transferred to icu in stable condition.Tee at end of case showed excellent valve function with minimal gradient.Endocarditis is an expected adverse event, defined in the aats/sts guidelines as valve-related and reportable, therefore this is being reported.It is among several other adverse events possible for heart valve patients as listed in section 5 of the ifu.

• 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: 5564710
• Report Number: 1649833-2016-70022
• Device Sequence Number: 394936
• Product Code: DYE
• UDI-Device Identifier: 00851788001440
• UDI-Public: 00851788001440
• 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: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2016

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: 04/01/2019
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2016
• Initial Report FDA Received Date: 04/08/2016
• 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: 59 YR