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-25

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

Patient Problems Stroke/CVA (1770); Heart Block (4444)

Event Date 05/06/2018

Event Type  Injury  

Event Description

According to the initial report, subject aap-098 in the aortic prosthesis (aap)- single site retrospective study, experienced two adverse events: on (b)(6) 2018 1 day post implant, subject experienced a stroke (cva).At time of event the subjects inr was 1.8.No further details were provided.On (b)(6) 2018, the subject experienced a complete heart block which required a permanent pacemaker to be implanted.Subject was discharged 3 days later.

Manufacturer Narrative

The manufacturing records for 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 device with serial number (b)(6) with a prefabricated ascending aortic graft of size 25 was implanted on (b)(6) 2018 in a 57-year-old male patient with a documented medical history of alcohol use, cva, type ii diabetes, hypertension, hyperlipidemia, sleep apnea, previous sternotomies, and an aortic aneurysm of the ascending aorta whose records were retrospectively acquired for a 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.This patient had an extensive cardiac surgical history that included an aortic valve bioprosthetic replacement, mechanical aortic valve replacement , aortic root replacement and descending thoracic replacement.In addition, during the pre-operative echocardiogram it was noted ¿mobile mass on lvot¿ and that he had lv outflow tract obstruction consisting of sub valvular pannus and thrombus.This event refers to study patient number (b)(6).On (b)(6) 2018 (1-day post implant), the patient was diagnosed with a cva ( cerebral vascular accident) , his inr was recorded as 1.8 and no further information was provided.Due to the lack of event information, we do not know whether the stroke is thromboembolic or hemorrhagic.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].If hemorrhagic, bleeding events also occur at a historical rate of 1.6 %/valve-year.With the available information, it is unknown what, if any, contribution the valve had to the occurrence of this stroke.In addition, the patient had a medical history of cva, hypertension and hyperlipidemia which are all considered risk factors for a cva event.On 14may2018 (9 days post implant) the patient was diagnosed with complete heart block and a permanent pacemaker was implanted; he was discharged home after 3 days.As the permanent pacemaker was implanted within 14 days of aortic valve replacement, the pacemaker implant is considered a valve related event per the atkins (2008) guidelines.The instructions for use [ifu] for the aap valve lists cardiac arrhythmia as a potential adverse event for mechanical prosthetic valve recipients.There is no indication that the on-x valve contributed in any way to the reported episode.However, it is reported here only for the purpose of consistency in documenting potential adverse events made known to the manufacturer and does not qualify for comparison to the historical record of valve performance.Due to the lack of information, it is unknown what kind of stroke took place nor the factors that may have led to its occurrence.It is also unknown what, if any, contribution the valve had to the event.Therefore, the root cause is unknown as well.The arrhythmia event is a probable consequence of the aortic valve replacement surgical procedure.The arrhythmia/pacemaker implantation is considered valve related as it occurred less than 14 days post aortic valve replacement.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 is accurate or has been confirmed by artivion.

Event Description

According to the initial report, subject aap-098 in the aortic prosthesis (aap)- single site retrospective study, experienced two adverse events: on (b)(6) 2018 1 day post implant, subject experienced a stroke (cva).At time of event the subjects inr was 1.8.No further details were provided.On (b)(6) 2018, the subject experienced a complete heart block which required a permanent pacemaker to be implanted.Subject was discharged 3 days later.

• 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: 14822894
• MDR Text Key: 295057163
• Report Number: 1649833-2022-00038
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 851788001532
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/01/2021
• Device Model Number: ONXAAP-25
• Device Catalogue Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/27/2022
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 87 KG