MAUDE Adverse Event Report: ARTIVION - FORMERLY CRYOLIFE/ARTIVION ¿ AUSTIN ON-X AAP UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number ONXAAP UNK

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/08/2011

Event Type  Injury  

Event Description

According to reports, subject in the post market study: (b)(6) (11/20)- post market clinical follow up study protocol of the on-x ascending aortic prosthesis (aap)- single site retrospective study.On the day of aortic valve replacement, information indicates that subject experienced ¿minor bleed¿ requiring transfusion.No medical records or additional details were provided.Inr on day of event was measured at 1.2.Product information unknown.No additional information will be provided.

• Brand Name: ON-X AAP UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION - FORMERLY CRYOLIFE/ARTIVION ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ARTIVION - FORMERLY CRYOLIFE/JOTEC ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 13863890
• MDR Text Key: 287712933
• Report Number: 1649833-2022-00008
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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
• Distributor Facility Aware Date: 02/22/2022
• Date Manufacturer Received: 02/22/2022
• 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