MAUDE Adverse Event Report: ARTIVION, INC. ¿ AUSTIN ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-25
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arrhythmia (1721); Tachycardia (2095)
Date of Event	07/17/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Post market clinical follow up study protocol of the on-x ascending aortic prosthesis (aap) - subject on 17jul2014 43 days post implant, subject experienced ventricular tachycardia.Subject was started on an iv of amiodarone and was discharged 5 days later.On (b)(6) 2015, subject experienced ventricular tachycardia was hospitalized for 3 days and then discharged, no other details of the event were provided.Product code and serial number are unknown.The valve remains implanted and will not be returned for evaluation.No additional information forthcoming.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• Common Device Name: 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: 14605341
• Report Number: 1649833-2022-00023
• Device Sequence Number: 12028241
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 851788001532
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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 Model Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown