MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXACE-23

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

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

Event Type  Injury  

Event Description

According to the initial report received on 10-aug-2021 from an on-x product tracking associate, "hospital reported a status of ¿disposed¿ assumed this to be an explant by same surgeon same hospital." additional information indicates that this valve was implanted in the patient on (b)(6) 2020.Additional information relays the patient came from an outside facility, and he had stopped taking his anticoagulant for sometime.

Event Description

According to the initial report received via email on 10-aug-2021 from s.P., on-x product tracking associate, "hospital reported a status of ¿disposed¿ assumed this to be an explant by same surgeon same hospital.Please notify me if this isn't an explant." additional information indicates that this valve was implanted in the patient on (b)(6) 2020.Additional information received from the cryolife sales representative relayed the following the patient came from an outside facility, and he had stopped taking his anticoagulant for sometime.No additional information is forthcoming.

• Brand Name: ONX AORTIC CONFORM EXT 23
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln. bldg. b; austin TX 78752
• MDR Report Key: 12336049
• MDR Text Key: 267049355
• Report Number: 1649833-2021-00030
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 39 YR