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

Model Number	ONXAE
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	12/28/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"serious injury" is closest applicable term, referring to re-operation, which is considered a "serious injury".Device not evaluated because it has not been returned.We are currently checking to see if it is still available for return so we can investigate.The re-operation which occurred on (b)(6) 2015 resulted in implant of an on-x onxae-21 valve.Follow-up exam with transthoracic echo took place on (b)(6) 2016, which is demonstrating a mild pvl.This patient's physician, dr.(b)(6), is requesting information on pvl with the on-x aortic valve/on-x valves.Asking if there is an increased level of pvl's with the on-x valve.A response was provided and a copy of that response is attached to this mdr.If the valve can be retrieved for investigation, a follow-up mdr will be filed to add the information from that evaluation.
Event or Problem Description
Patient had aortic valve replacement (avr) on (b)(6) 2015.Over 4 months post-operative, he developed paravalvular leak (pvl).It was observed in follow-up echos and monitored for several weeks, after which it was decided to go through a re-do avr to correct the pvl.The patient did not exhibit associated symptomatology (e.G., heart failure).The operative findings were that the surgeon could not find any pathology and the leak and paravalvular problem could never be identified.The leak was described as moderate at most by volumetric analysis.The re-do avr was pursued anyway.This is being reported because pvl is defined in the aats/sts guidelines as valve-related and reportable.Pvl is among the expected adverse events that can occur in a heart valve patient, as listed in section 5 of the ifu.Pvl is occurring well-within expected frequency and no trend is seen.Patient status: patient is status post 2nd avr, is currently asymptomatic showing no clinical sequelae at this time.Showing echo evidence of re-occurrence of pvl mild.

• 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: 5488426
• Report Number: 1649833-2016-70013
• Device Sequence Number: 386206
• Product Code: DYE
• UDI-Device Identifier: 00851788001402
• UDI-Public: 00851788001402
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/09/2016

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: 05/11/2021
• Device Model Number: ONXAE
• Device Catalogue Number: ONXAE-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 03/09/2016
• 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: 55 YR