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

Model Number	ONXACE
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Test Result (2695)
Date of Event	11/30/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Patient reported to on-x on (b)(6) 2016, that 11 days post-operatively he had to return to the hospital with an inr of 6.8 and that his pericardial sac had filled with over a liter of blood.Due to his condition medical staff did an emergency removal of blood with a needle through the chest, with no time for anesthesia.The sac was then emptied.The valve remains implanted.This is being reported because it is a bleeding event, which is defined in the aats/sts guidelines as valve-related, and that the bleeding event required immediate medical intervention to prevent permanent injury.Thus, this is being treated as reportable.There is no further information on why his anticoagulation was so far out of range.

• 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: 5442537
• Report Number: 1649833-2016-70006
• Device Sequence Number: 302559
• Product Code: DYE
• UDI-Device Identifier: 00851788001471
• UDI-Public: 00851788001471
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/17/2016

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: 08/19/2019
• 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: 01/18/2016
• Initial Report FDA Received Date: 02/17/2016
• 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: 26 YR