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 Endocarditis (1834); Unspecified Infection (1930); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

According to the initial report, surgeon had four patients recently that received onxaaps end up with infections.Two required take back to the operating room for washout due to pericardial effusions/mediastinal fluid collections.Swabs were taken of the mediastinal fluid and did not grow any organisms.All four patients had elevated wbc [white blood cell] counts.Indium nuclear wbc scan were positive on all four with uptake around the aorta.This investigation is relegated to one of the four patients with date of implant: (b)(6) 2023.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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.

Manufacturer Narrative

On 30june2023 a representative from artivion was informed that a surgeon recently implanted aap devices in 4 patients that all ended up developing endocarditis.Specific patient/case information was not provided.This investigation is relegated to sn (b)(6)implanted on (b)(6) 2023.Additional information was obtained from the surgeon¿s physician¿s assistant: ¿none of the 4 patients were diagnosed with endocarditis and none had a history of endocarditis pre-op.All 4 patients were screened pre-op for dental abscess, all negative.None were explanted, all were initiated on empiric iv abx (antibiotics) once showed s/sx (signs and symptoms) of infection during the work up.Two required take back to the operating room for washout due to pericardial effusions/mediastinal fluid collections.Swabs were taken of the mediastinal fluid and did not grow any organisms.All 4 patients had elevated wbc (white blood cell) counts.Indium nuclear wbc scan were positive on all 4 with uptake around the aorta.¿ the aap devices were not explanted in any of the 4 cases so there was no further testing done of the device by either the hospital or manufacturer.The manufacturing records 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.During the investigation no non-conformances or deviations were noted.Additionally, the four devices were from different manufacturing batches, three from 2021 and one from 2020 and each was from a different sterilization batch.With the information provided, the source of the endocarditis is unknown.However, because all on-x aap devices undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the infection.The instructions for use (ifu) for the on-x valve states that reoperation, including explantation, may result from a complication, in this case, endocarditis, a known potential event acknowledged in the ifu.Though rare, historically, endocarditis occurs at a rate of 0.3 %/patient-year for mechanical aortic heart valves [iso 5840-2:2021].References: iso 5840-2:2021 (e) cardiovascular implants- cardiac valve prostheses, annex i.On-x® ascending aortic prosthesis with the vascutek gelweave valsalvatm graft, instructions for use.Http://www.Onxlti.Com/ifu/.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.

• 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: 17350575
• MDR Text Key: 319298768
• Report Number: 1649833-2023-00024
• Device Sequence Number: 1
• Product Code: LWQ
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/01/2024
• Device Model Number: ONXAAP-25
• Device Catalogue Number: ONXAAP-25
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2021
• 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