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

Model Number ONXAAP-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Thromboembolism (2654); Ischemia Stroke (4418)

Event Date 03/09/2022

Event Type  Injury  

Event Description

According to the initial report received, study patient experienced an ischemic stroke on (b)(6) 2022, 1-day following implant with the device (implanted on (b)(6) 2022).

Manufacturer Narrative

The manufacturing records for onxaap-21, sn (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.An onxaap 21 with serial number (b)(6) was implanted on (b)(6) 2022 with a concomitant coronary artery graft bypass (cabg) x1 svg-rca in a 42-year-old female with a past medical history of svt, hypothyroid, hypertension, presumed asthma, congenital bicuspid aortic valve and ascending aortic aneurysm with a previous ascending aortic aneurysm repair in 2005 and an aortic valve replacement with a carbomedics 19mm valve in 2014.The subject was enrolled in the study and this event refers to study patient.On (b)(6) 2022 (1-day post implant), the patient¿s sedation was paused for approximately two hours to perform a neurological check, this was the first full neuro exam performed since prior to the surgery.There was right upper extremity and right lower extremity weakness noted.Vital signs as follows: b/p 163/51, bg (blood glucose) 155, nihss (national institute of health stroke scale) 14 for drowsiness, aphasia (intubated) and no effort against gravity in the right upper extremity and bilateral lower extremities and some effort against gravity in the left upper extremity.A non-contrast head ct was performed and showed hypodensity involving the left frontal lobe, parietal lobe, and insula.A ct angiogram of the head was also performed and showed left m2 occlusion with estimated 70% core infarction.A neurology consult was ordered, and the physician noted the patients stroke risk factors as severe aortic stenosis and hypertension.The treatment plan was to wait 7-14 days to initiate anticoagulation for the heart valve to reduce the risk of hemorrhagic conversion.A repeat head ct on 11mar was ordered and if unchanged to begin patient on low dose heparin drip and suspend all antiplatelets.Every one-hour neurological exams were ordered along with keeping spb over 140.Thromboembolism is recognized as a potential adverse event in the instructions for use [ifu] and occurs at a historical rate of 1.6 %/valve-year for mechanical aortic valves [iso 5840].It is unknown if the valve was directly related to the incidence of ischemic stroke or if it was a complication that occurred during the surgical procedure/as a result of the surgical process as it was discovered during the first neurological exam after surgery as the patient was under constant sedation until this time.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion- formerly cryolife/jotec is accurate or has been confirmed by artivion.References: on-x® ascending aortic prosthesis with the vascutek gelweave valsalvatm graft, instructions for use.Iso 5840-2:2021 (e) cardiovascular implants - cardiac valve prostheses, annex i.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15933004
• MDR Text Key: 304991425
• Report Number: 1649833-2022-00060
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001518
• UDI-Public: 851788001518
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXAAP-21
• Device Catalogue Number: ONXAAP-21
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 99 KG