MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC ANATOMIC 21; HEART-VALVE, MECHANICAL

Model Number ONXAN-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Endocarditis (1834)

Event Date 08/24/2021

Event Type  Injury  

Event Description

According to the initial report, onxan-21 sn (b)(4) was implanted on (b)(6) 2016 and explanted on (b)(6) 2021.Additional information was received, onxan-21 had to be removed because of pve (prosthetic valve endocarditis) it got infected and there was a root abscess.

Event Description

According to the initial report, onxan-21 sn (b)(6) was implanted on (b)(6) 2016 and explanted on (b)(6) 2021.Additional information was received, onxan-21 had to be removed because of pve (prosthetic valve endocarditis) it got infected and there was a root abscess.

• Brand Name: ONX AORTIC ANATOMIC 21
• Type of Device: 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: 12656101
• MDR Text Key: 277133451
• Report Number: 1649833-2021-00037
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/24/2021
• Device Model Number: ONXAN-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/01/2021
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male