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

Model Number	ONXACE
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Thrombosis (2100)
Date of Event	10/22/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Chose "serious injury" because patient required re-operation, which for a heart valve is like a serious injury.The real issue was "adverse event".Device history records review: the device was manufactured per specifications.
Event or Problem Description
Per operative notes obtained from the hospital, the patient was re-operated, revealing a leaflet in his on-x prosthetic aortic valve was completely embedded in a mixture of fresh and old thrombus.The other leaflet was also immobile.The mechanical valve was explanted and a tissue valve was implanted in its place.The patient was known to be missing some of his inr management appointments.On admission, his inr was subtherapeutic.The patient did well, transferred to icu in stable condition.Discharged home on post-op day #4.Reason for reporting: valve thrombosis is an expected adverse event, listed in the ifu section 5.Per aats/sts guidelines, valve thrombosis is defined as valve-related and reportable.This event occurs well within expected frequency and there is no trend observed.

• 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: 5466125
• Report Number: 1649833-2016-70008
• Device Sequence Number: 16213705
• Product Code: DYE
• UDI-Device Identifier: 00851788001471
• UDI-Public: 00851788001471
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/29/2016

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: 09/27/2018
• 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: 02/12/2016
• Initial Report FDA Received Date: 02/29/2016
• 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: 62 YR