MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART VALVE MECHANICAL

Model Number	ONXMC-25/33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
According to initial reports from the patient, "i have your onxmc-25/33 mitral valve replacement since (b)(6) i had a major bleeding episode on warfarin a year ago.Don't want another.However my cardiologist is raising the inr range for my valve.Patient contacted cryolife with concerns about her physician increasing her inr recently.As of (b)(6) 2017 the patient's inr is 2.0.The patient's concern stem's from a bleeding incident in (b)(6) 2016 the resulted in a two week hospitalization.
Additional Manufacturer Narrative
A review of the available information was performed.The manufacturing records for the onxmc-25/33 sn (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.Initially reported, an onxmc-25/33 sn (b)(4) was implanted in the mitral position of a (b)(6) year old female patient on (b)(6) 2009.Patient is reporting a major bleeding event from over a year ago, namely, (b)(6) 2016 (7 years and 272 days postop), during which time she experienced bleeding from her back (no broken skin) and spent two weeks in a hospital.Inr at the time of the event is not known.Current inr on (b)(6) 2017 was 2.0.The patient is concerned because her cardiologist wants to increase her inr and does not want a repeated episode of bleeding.It is difficult to ascertain the source of the bleeding from the back if there is no broken skin.Was it oozing out in a general fashion or was it concentrated in some region? we don't know the inr at the time of the event, so we do not know whether or not she was in the recommended range.Without other risk factors, the standard-of-care target for a mechanical mitral valve recipient is 3.0 (range 2.5 to 3.5) [nishimura 2017], so the cardiologist, seeing the current 2.0, is following the guidance.Maintaining the proper balance of anticoagulant is critical.Bleeding is a recognized potential complication for mechanical mitral valve recipients [instructions for use].The objective performance criteria lists a rate of major hemorrhage for rigid valve recipients of 1.5%/pt-year [iso 5840:2005].The root cause for this event is unknown.No further action is warranted at this time.
Event or Problem Description
According to initial reports from the patient, "i have your onxmc-25/33 mitral valve replacement since (b)(6) 2009.I had a major bleeding episode on warfarin a year ago.Don't want another! however my cardiologist is raising the inr range for my valve." patient contacted cryolife with concerns about her physician increasing her inr recently.As of (b)(6) 2017 the patient's inr is 2.0.The patient's concern stem's from a bleeding incident in (b)(6) of 2016 the resulted in a two week hospitalization.

• Brand Name: ONX MITRAL CONFORM 25/33
• Common Device Name: HEART VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 6845056
• Report Number: 1649833-2017-00065
• Device Sequence Number: 18848430
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 851788001303
• Combination Product (Y/N): N
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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: Physician
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/10/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/06/2017
• 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: Hospitalization; Required Intervention