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

Model Number ONXAAP UNK

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Tamponade (2226); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/15/2013

Event Type  Death  

Event Description

According to reports, subject in the post market study: ox1901.000-m (11/20)- post market clinical follow up study protocol of the on-x ascending aortic prosthesis (aap)- single site retrospective study - on post op day 5 prior to hospital discharge from aortic valve replacement, subject experienced cardiac tamponade and underwent emergency sternotomy and closure of epicardial bleed with rigid sternal fixation.Inr at time of event was measured at 3.0.Additionally, the subject experienced a large collection of fluid surrounding the ascending aorta and hemiarch site of the prior repair in 2011.Bleeding around suture line which compressed coronary arteries presenting a global ischemic picture.Notes indicate that a right heart catheterization was performed but outcome of event was death of subject.Written notes indicate respiratory failure, biventricular failure and cardiogenic shock as cause of death on day of event of (b)(6) 2013.Inr at time of event was measured at 5.7.Date of tamponade july 14, 2011.Date of death (b)(6) 2013.No medical records or source documents were provided.Product information unknown.No further information available.

• Brand Name: ON-X AAP UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION - FORMERLY CRYOLIFE/JOTEC ¿ 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 ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 13864463
• MDR Text Key: 287771205
• Report Number: 1649833-2022-00009
• 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): Death; Other
• Patient Age: 54 YR
• Patient Sex: Female