MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTICPROSTHESISWITH THE VASCUTEKGELWEAVEVALSALVA¿ GRAFT; HEART-VALVE, MECHANICAL

Model Number ONXAAP-23

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

Patient Problems Atrial Fibrillation (1729); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Cardiac Tamponade (2226); Pericardial Effusion (3271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2015

Event Type  Injury  

Event Description

According to the initial report, subject (b)(6) in the aortic prosthesis (aap)- single site retrospective study, experienced two adverse events: on (b)(6) 2015 8 days post implant, subject experienced afib, hypertension and dyslipidemia lasting 1 day.Inr at time of hospitalization was 2.2.No further details were provided.On (b)(6) 2015, the subject experienced pericardial effusion with tamponade and paroxysmal atrial tachycardia.The subject received a pericardial window and left thoracostomy tube and was discharged 5 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 on-x valve with serial number (b)(6) with a prefabricated ascending aortic graft of size 23 was implanted with concomitant procedures related to an aortic dissection repair on (b)(6) 2015 in a 48 year old male with a past medical history of alcohol use, hypertension, undiagnosed heart murmurs, sleep apnea, bicuspid valve disease, aortic aneurysm or the arch, root and ascending aorta, aortic dissection and aortic valve calcification of the leaflets 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 event refers to study patient number (b)(6) on (b)(6) 2015 (7 days post implant) the patient experienced atrial fibrillation with rapid ventricular rate (a fib with rvr) and was readmitted to the hospital for one day.No interventions were noted, and the patient was discharged home.On (b)(6) 2015 (12 days post implant) the patient was readmitted with diagnoses of pericardial effusion with tamponade and paroxysmal atrial tachycardia , dyslipidemia, hypertension , and left pleural effusion.His inr was recorded as unknown at the time of admission.On (b)(6) 2015 (13 days post implant) he underwent a pericardial window procedure and a left thoracostomy tube was inserted.He was discharged home after 5 days.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.The event 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.As the event of tamponade happened 12 days post-implant, this would not be a spontaneous bleeding event due to the valve or anticoagulation therapy, but more likely a sequela of the trauma of surgery and therefore not a reportable bleeding event under the definition of akins, et al.[akins 2008].It is reported here only for the purpose of consistency in documenting adverse events made known to the manufacturer and does not qualify as a bleeding event for comparison to the historical record of valve performance.Cardiac arrhythmia is a known potential complication, however, there is no indication that the on-x valve contributed in any way to the reported episode.Pericardial effusion and tamponade caused by fluid accumulation is most likely a consequence of a leaking suture line and is not likely related to the performance of the on-x valve itself.As his anticoagulation status is unknown we cannot rule out an elevated inr as an exacerbating the event.No further action is required without further information.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 (b)(6) in the aortic prosthesis (aap)- single site retrospective study.Experienced two adverse events: on (b)(6) 2015, 8 days post implant, subject experienced afib, hypertension and dyslipidemia lasting 1 day.Inr at time of hospitalization was 2.2.No further details were provided.On (b)(6) 2015, the subject experienced pericardial effusion with tamponade and paroxysmal atrial tachycardia.The subject received a pericardial window and left thoracostomy tube and was discharged 5 days later.

• Brand Name: ON-X ASCENDING AORTICPROSTHESISWITH THE VASCUTEKGELWEAVEVALSALVA¿ 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: 14822843
• MDR Text Key: 295040372
• Report Number: 1649833-2022-00037
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 851788001525
• 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: 01/01/2020
• Device Model Number: ONXAAP-23
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 93 KG