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

Model Number	ONXANE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
As per the request submitted by fda medwatch program, this report is being resubmitted as report number 1649833-2016--70018-1.This report was initially submitted as 1649833-2016-70014 - 1, march 31, 2016.Description from medwatch report as follows: this is a follow-up report to the original mor no.1649833-2016-70014.Event occurred in romania.A leaflet was broken while attempting rotation of the valve.The valve has been returned and investigated.Evidence suggests that the housing was rotated either by an under size rotator or other method outside the scope of the valve instructions for use (ifu) resulting in leaflet fracture and subsequent valve housing damage.In brief, it is summarized as "iatrogenic damage".The ifu clearly warns against using undersize rotators or other non-on-x instrument as it can result in damage.This was not a structural valve dysfunction caused by latent defect in the valve.

• 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: rochelle maney ; 1300 e. anderson ln; bldg b; austin, TX 78752 ; 7704193355
• MDR Report Key: 5538828
• Report Number: 1649833-2016-70018
• Device Sequence Number: 11677302
• Product Code: DYE
• UDI-Device Identifier: 00851788001662
• UDI-Public: 00851788001662
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/24/2019
• Device Model Number: ONXANE
• Device Catalogue Number: ONXANE-23
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 03/31/2016
• Supplement Report FDA Received Date: 03/31/2016
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2014
• 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
• Patient Sex: Unknown