MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC STANDARD EXT 27/29; HEART-VALVE, MECHANICAL

Model Number	ONXAE-27/29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the implant registration cards received, this patient was implanted with onxae-27/29 sn (b)(4) on (b)(6) 2016 and explanted on (b)(6) 2022.Cause of explant is still currently unknown.
Event or Problem Description
According to the implant registration cards received, this patient was implanted with onxae-27/29 sn (b)(6) on (b)(6) 2016 and explanted on (b)(6) 2022.Cause of explant is still currently unknown.

• Brand Name: ONX AORTIC STANDARD EXT 27/29
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 14206911
• Report Number: 1649833-2022-00011
• Device Sequence Number: 1803245
• Product Code: LWQ
• UDI-Device Identifier: 00851788001426
• UDI-Public: 851788001426
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 04/14/2022
• Device Model Number: ONXAE-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Unknown