MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number ONXAE-21

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2022

Event Type  Death  

Event Description

On september 1, 2022 the fda forwarded a medwatch report (b)(4) which was submitted by the user facility identifying an artivion product.According to the report, "patient had an aortic valve replacement with usage of a mechanical valve.Surgery without complications.Patient died several days later at home." the procedure was reported as "aortic valve replacement with left atrial appendage ligation." additional information reported states: "inr only got as high as 1.2 before patient died." the patient was identified as a 47-year old female, weighing 221 lbs., with the following pre-existing conditions: "diabetes; hypertension; morbidly obese." additional information was received on 9/7/2022: "the patient's native valve was replaced with an onx valve.The cause of death is unknown and the family refused an autopsy.The records [medical records, operative notes, re-operative notes] are not being released.".

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

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.The device was implanted in the aortic position in a 47-year-old female patient and on (b)(6) 2022 a medwatch report was forwarded to the manufacturer after a report was filed by the operating hospital that the patient passed at home.The date of implant is listed as ¿on (b)(6) 2022¿ and the date of death as on (b)(6) 2022.According to the medwatch report the patient underwent and aortic valve replacement with a mechanical valve and a concomitant left atrial appendage ligation.In the report the surgery was described as ¿without complication¿ and no further medical records are available.The only other information provided was that the patient had a past medical history of diabetes, hypertension and morbid obesity and following the implant an inr described as ¿inr only got as high as 1.2 before patient died.¿ the report states the patient died ¿several days later¿ and in follow up information received on 7sept2022, "the cause of death is unknown, and the family refused an autopsy." we do not have a discharge summary or any post-surgical information other than the medwatch report and with this limited information we have no evidence to indicate what, if any, contribution the valve had to this unfortunate clinical outcome.Although there is no evidence of valve involvement, the instructions for use lists death as a possible complication of mechanical heart valve replacement [ifu].Predictions of operative mortality after aortic valve replacement surgery show an operative mortality rate of 1.9% (bowdish).There is insufficient information to indicate a root cause for the death.The risk management and usability engineering file was reviewed.There is insufficient information to indicate a root cause for the death; thus, severity and occurrence is not evaluated.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible and residual risk is acceptable.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING AND EXTENDED HOLDER
• 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: 15438793
• MDR Text Key: 300057208
• Report Number: 1649833-2022-00048
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001396
• UDI-Public: 851788001396
• 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,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXAE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 100 KG