MAUDE Adverse Event Report: ARTIVION/CRYOLIFE, INC. ¿ AUSTIN ONX AORTIC ANATOMIC EXT 23; HEART-VALVE, MECHANICAL

Model Number	ONXANE-23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to implant registration card returned from the user facility, onxane-23 sn (b)(4) was implanted (b)(6), 2022 in a patient with an existing onxane-23 sn (b)(4), (b)(6), 2020.Both ircs notate the valves were implanted in the aortic position.This investigation will be relegated to onxane- 23 sn (b)(4).

• Brand Name: ONX AORTIC ANATOMIC EXT 23
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION/CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ARTIVION/CRYOLIFE, 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: 13742179
• Report Number: 1649833-2022-00005
• Device Sequence Number: 14623887
• Product Code: LWQ
• UDI-Device Identifier: 00851788001662
• UDI-Public: 851788001662
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: ONXANE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 04/19/2022
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male