MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC 25; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	12/28/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received subject: aap- 059 on (b)(6) 2013 11 days prior to implant, subject experienced endocarditis of the annuls [annulus].There were several procedures performed but only 2 can be identified from the adverse event form, redo sternotomy and a hemi arch replacement.No further details were provided.A review of the available information relayed the patient had a valve implanted in 2013 but then underwent redo in 2014.(the pre-op echo crf data indicates vegetation was present).The timeline extracted: (b)(6) 2013- initial replacement (b)(6) 2013- ae start date per crf (case report form) (b)(6) 2013- pre-op echo (b)(6) 2014- re-do with onx implant all crfs indicate some sort of vegetation on the various echo findings.In light of the dates, i want to say the endocarditis was pre-existing.The information provided is all we will be able to get from the site.This investigation is relegated to onxaap-25 serial number: (b)(4).No additional information forthcoming.
Event or Problem Description
According to the initial report received subject: aap- 059 on 28dec2013 11 days prior to implant, subject experienced endocarditis of the annuls.There were several procedures performed but only 2 can be identified from the adverse event form, redo sternotomy and a hemi arch replacement.No further details were provided.A review of the available information relayed the patient had a valve implanted in 2013 but then underwent redo in 2014.(the pre-op echo crf data indicates vegetation was present).The timeline extracted: ¿ (b)(6) 2013- initial replacement ¿ 12/28/2013- ae start date per crf (case report form) ¿ 12/30/2013- pre-op echo ¿ (b)(6) 2014 re-do with onx implant.All crfs indicate some sort of vegetation on the various echo findings.In light of the dates, i want to say the endocarditis was pre-existing.The information provided is all we will be able to get from the site.This investigation is relegated to onxaap-25 serial number: (b)(4).No additional information forthcoming.

• Brand Name: ON-X ASCENDING AORTIC 25
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson ln, bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson ln, bldg b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 14347198
• Report Number: 1649833-2022-00014
• Device Sequence Number: 12046529
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 851788001532
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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
• Device Expiration Date: 05/31/2017
• Device Model Number: ONXAAP-25
• Device Catalogue Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male