MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC ANATOMIC EXT 19; HEART-VALVE, MECHANICAL

Model Number	ONXANE - 19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the report received via email on 16-jun-2021, "patient is subject # 370 in the on-x post approval study.Patient was hospitalized for a pacemaker related reason.No other details are available at this point." per the adjudication form during this hospitalization the patient had a pacemaker implanted.This is not related to the implanted on-x valve.Additional information received relayed the patient was admitted on (b)(6) 2019 for elective left knee replacement.On (b)(6) 2019 the patient awoke with bilateral blurry vision, and is being evaluated for stroke.(b)(6) 2019: ct of head - occipital lobes with bilateral hypodensity.Right parietal lobe hypodensity.Suggestive of evolving infarcts vs pres.Assessment: suspected acute infarcts involving the occipital + parietal lobes related to being off of anticoagulation + mechanical valve.
Event or Problem Description
According to the report received via email on 16-jun-2021, "patient is subject # 370 in the on-x post approval study.Patient was hospitalized for a pacemaker related reason.No other details are available at this point." per the adjudication form during this hospitalization the patient had a pacemaker implanted.This is not related to the implanted on-x valve.Additional information received relayed the patient was admitted on (b)(6) 2019 for elective left knee replacement.On (b)(6) 2019 the patient awoke with bilateral blurry vision, and is being evaluated for stroke.(b)(6) 2019: ct of head - occipital lobes with bilateral hypodensity.Right parietal lobe hypodensity.Suggestive of evolving infarcts vs pres.Assessment: suspected acute infarcts involving the occipital + parietal lobes related to being off of anticoagulation + mechanical valve.

• Brand Name: ONX AORTIC ANATOMIC EXT 19
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson ln bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson ln bldg b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 14403660
• Report Number: 1649833-2022-00015
• Device Sequence Number: 5473847
• Product Code: LWQ
• UDI-Device Identifier: 00851788001648
• UDI-Public: 851788001648
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/31/2022

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 Expiration Date: 10/18/2024
• Device Model Number: ONXANE - 19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 05/31/2022
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 107 KG