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

Model Number	ONXANE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Iatrogenic Source (2498)
Date of Event	02/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet evaluated because it has not yet been received, it is on its way at this time.Investigation will entail fracture analysis.When the investigation is complete, a follow-up mdr will be filed.Review of device history record: concludes that valve was manufactured per specifications.
Event or Problem Description
Distributor in (b)(4) reported event as follows: "on (b)(6) 2016 during an implant procedure, at the moment when the physician tried to rotate the valve using the dedicated tool from the kit, the valve did not rotate but a leaflet became detached.The valve was replaced with another one in order to continue the surgical procedure." the valve is being returned for investigation, has not yet arrived.Investigations of all such instances of carbon part damage have been concluded to be "iatrogenic", usually not following the ifu warnings.This is the expected conclusion in this case, because use of the correct size rotator instrument will not transmit rotational forces to the leaflets.After the investigation is complete, a follow-up mdr will be filed.

• 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: 5491866
• Report Number: 1649833-2016-70014
• Device Sequence Number: 330628
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2016

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 03/10/2016
• 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