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

Model Number	ONXM-31/33
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Mitral Valve Stenosis (1965)
Date of Event	10/17/2006
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 the (b)(6), patient implanted with onxm 31/33 on (b)(6) 2006 and required intervention/explant due to "bioprosthetic mitral stenosis" on (b)(6) 2016 and was replaced with an onxmc-25/33.
Additional Manufacturer Narrative
According to the implant registration card (irc) forwarded on 09/02/2016, a patient was implanted with an on-x mitral heart valve ¿ 31/33 mm, sn (b)(4), (onxm-31/33) on (b)(6) 2006 and required intervention/explant due to ¿bioprosthetic mitral stenosis¿ on (b)(6) 2016 and was replaced with onxmc-25/33. attempts to obtain additional clarifying information (including operative notes) from the hospital regarding the reported event were unsuccessful.A phone conversation was conducted on 10/26/2016 with the receptionist for the surgeon in which it was indicated that no further information about the patient would be released without a signed release from the patient.Should additional information become available it will be evaluated. the manufacturing records for the onxm-31/33, sn (b)(4), were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.The onxm-31/33 (sn (b)(4)) was implanted (b)(6) 2006 in the mitral position via mitral valve replacement (mvr) and was replaced by an onxmc-25/33 (sn (b)(4)) on (b)(6) 2016 (9 years 272 days postop).Conflicting information contained on the irc for the new valve indicates that the reason for explantation of the prior valve is "bioprosthetic mitral stenosis." the on-x valve is not a bioprosthetic device and requests for additional information were unsuccessful, so the intent of the note cannot be established.Consequently, there is insufficient information available to ascertain what, if any, relationship the explantation has to the valve.Reoperation and explantation are known risks of prosthetic heart valves of any brand and type and are not unique to the on-x valve.Both events are listed in the potential adverse events section found in the onxm and onxmc instructions for use (ifu).
Event or Problem Description
According to the implant registration card (irc) forwarded  on 09/02/2016, a patient was implanted with an on-x mitraheart valve ¿ 31/33 mm, sn (b)(4), (onxm-31/33) on (b)(6) 2006 and required intervention/explant due to ¿bioprosthetic mitral stenosis¿ on (b)(6) 2016 and was replaced with onxmc-25/33.

• Brand Name: ON-X MITRAL HEART VALVE
• 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: 5986527
• Report Number: 1649833-2016-00060
• Device Sequence Number: 16279078
• Product Code: LWQ
• UDI-Device Identifier: 00851788001297
• UDI-Public: 00851788001297
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2016

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: Physician
• Device Model Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2016
• Supplement Report FDA Received Date: 12/05/2016
• 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: Other
• Patient Age: 31 YR