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-27/29

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

Patient Problem Arrhythmia (1721)

Event Date 04/12/2020

Event Type  Injury  

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.

Event Description

According to the initial report received, patient in the study experienced cardiac arrhythmia on (b)(6) 2020, following implant with the onxaap (implanted (b)(6) 2020).

Manufacturer Narrative

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.An onxaap 27/29 was implanted on (b)(6) 2020 in a 44-year-old male with a past medical history of aortic insufficiency with a bicuspid aortic valve, hypertension, hyperlipidemia, chronic obstructive pulmonary disease and an ascending aortic aneurysm.The subject was enrolled in a study.On (b)(6) 2022 (2 days post implant), the patient experienced an episode of atrial fibrillation with rapid ventricular response (a fib with rvr) that was nonresponsive to medications at first.The patient was given an amiodarone bolus and placed on an amiodarone drip.On (b)(6) 2023 (3 days post implant), the patient was noted to be back in normal sinus rhythm (nsr) and the amiodarone drip was continued.On (b)(6) 2022 (4 days post implant), the patient remained in nsr and the amiodarone drip was discontinued, and they were transitioned to oral amiodarone 200mg twice daily.On (b)(6) 2020 (7 days post implant), the patient was discharged home and was in nsr at the time of discharge.The instructions for use [ifu] for the aap valve list 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 and it is more likely a complication related to the surgical procedure itself rather than the valve.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: 16496304
• MDR Text Key: 310807491
• Report Number: 1649833-2023-00009
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001549
• UDI-Public: 851788001549
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/01/2022
• Device Model Number: ONXAAP-27/29
• Device Catalogue Number: ONXAAP-27/29
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/07/2023
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 93 KG