MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN 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 Transient Ischemic Attack (2109)

Event Date 05/06/2021

Event Type  Injury  

Event Description

According to initial reports, "patient with onxace-23 sn (b)(4) implanted (b)(6) 2016.The patient is healthy.While playing with children in the yard the patient experienced a tia event and double vision.Patient was running at an inr close to 1.5 but the doctor brought it up as a pre-caution.This investigation is relegated to onxace-23 sn (b)(4).

• Brand Name: ONX AORTIC CONFORM EXT 23
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30014 ; 7704193355
• MDR Report Key: 11895855
• MDR Text Key: 266927625
• Report Number: 1649833-2021-00017
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 00851788001464
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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 Operator: No Information
• Device Expiration Date: 08/16/2022
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/06/2021
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR