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

Model Number	ONXACE
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As per the request submitted by fda medwatch program, this report is being resubmitted as report number 1649833-2016--70010-1.This report was initially submitted as 1649833-2015-70027 - 1, april 28, 2016.Description from original follow-up medwatch report as follows: while entering tracking database implant information, a patient was observed to have received a second implant of the same position (aortic).The surgeon's office was contacted and the operative notes were obtained, which explain why the re-do aortic valve replacement (avr) was done.The patient was diagnosed with paravalvular leak (pvl).Patient was re-operated and a new valve onxace-21 s/n (b)(4) was implanted.The valve being explanted had dehisced just right of the right coronary commisure.Lntraop transesophageal echo showed no pvl post valve replacement.Patient transferred to icu having tolerated the re-op well.The reason this is being reported is pvl is defined in the aats/sts guidelines as valve-related and reportable.It is also an expected adverse event, and is listed among the expected adverse events possible for a heart valve patient, 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 TECHNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• Manufacturer Contact: teresa macias ; 1300 e. anderson ln; bldg b; austin, TX 78752 ; 7704193355
• MDR Report Key: 5471831
• Report Number: 1649833-2016-70010
• Device Sequence Number: 4220514
• Product Code: DYE
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• Combination Product (Y/N): Y
• 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: 2012
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Device Expiration Date: 09/21/2017
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-21
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2016
• Supplement Date Received by Manufacturer: 04/14/2016
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 03/01/2016
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male