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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/29/2017
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 an email received on 04/02/2018: "while entering sn (b)(4) onxmc 25/33 the system notified me of a previous implant in same position for same patient." previous implant is associated with onxmc 25/33 sn (b)(4) and this valve is the one being investigated.
Event or Problem Description
According to an email received on (b)(6)2018: "while entering sn (serial number) for onxmc 25/33 the system notified me of a previous implant in same position for same patient." previous implant is associated with another onxmc 25/33 and this valve is the one being investigated.
Additional Manufacturer Narrative
The manufacturing records for the onxmc-25/33 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.During the investigation no non-conformances or deviations were noted. onxmc-25/33 was implanted on (b)(6)2013.In the mitral position of a 52.7 year old male; explanted and replaced (b)(6)2017 (4.9 years postop) by another onxmc-25/33 as reported to manufacturer¿s device tracking registration database.The explanted valve was not returned to the manufacturer and no other information was made available.The instructions for use (ifu) note the risk of explantation as a consequence of a complication, but no information was given on what complication prompted the procedure.Consequently, there is not enough information to know what, if any, relationship the explantation has to the valve.No further action is required.There is insufficient information available to determine a definitive root cause.A review of manufacturing records indicates that the valve was built per specification. this report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• 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: 7475896
• Report Number: 1649833-2018-00023
• Device Sequence Number: 2222366
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 851788001303
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 04/02/2018
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 07/02/2018
• 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
• Patient Age: 57 YR