MAUDE Adverse Event Report: ARTIVION, INC. ¿ AUSTIN ON-X AAP UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number ONXAAP UNK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/20/2020

Event Type  Injury  

Event Description

Subject in aortic prosthesis (aap)- single site retrospective study experienced acute hemorrhage of the basal ganglia (b)(6) 2020.At time of hospitalization the subject's inr was 2.3.They were discharged 14 days later on (b)(6) 2020.

• Brand Name: ON-X AAP UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 14802908
• MDR Text Key: 295040258
• Report Number: 1649833-2022-00035
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXAAP UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/27/2022
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization