MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pleural Effusion (2010)

Event Date 02/04/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to returned implant notifications from the user facility, onxm-31/33 sn (b)(4) and onxae-25 sn (b)(4) were implanted in the mitral position in the same patient on the same day.This investigation is relegated to onxm-31/33 sn (b)(4).Additional information received.The onxm-31/33 was the mitral and placed in the mitral position.The onxae-25 was placed as an aortic valve.Patient is deceased.Cause of death - pleural effusion.No additional information forthcoming.

Manufacturer Narrative

According to returned implant notifications from the user facility, onxm-31/33 sn: (b)(6), onxmc-25/33, sn: (b)(6) and onxae-25 sn: (b)(6) were implanted in the mitral position in the same patient on the same day.An obituary found online for the patient suggested the patient died on (b)(6) 2020 from complications due to endocarditis.This investigation is relegated to onxm-31/33 sn: (b)(6).The onxae-25 sn: (b)(6) will be investigated separately.Additionally, the following clarifying information was received from the user facility.¿the onxm-31/33 was the mitral and placed in the mitral position.The onxmc-25/33 was opened in error.The onxae-25 was placed as an aortic valve and should have reflected as such.Patient is deceased.Cause of death, pleural effusion.¿ no additional information forthcoming.The manufacturing records for the onxm-31/33 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.Change order for leaflet tuning performed as a part of the standard manufacturing process.A review of the available information was performed.According to implant registration cards (irc), three on-x valves were reported as used in the mitral position for the same patient on the same day of surgery: onxm-31/33 sn: (b)(6), onxmc-25133 sn: (b)(6), and onxae-25 sn: (b)(6) on (b)(6) 2020.Follow-up clarification from the site indicated that the onxm-31/33 was implanted in the mitral position, the onxae-25 was implanted in the aortic position, and the onxmc-25/33 was opened by mistake.This would be a double-valve replacement case, mitral and aortic, of a 50-year-old male.Communication with the site indicated the patient was deceased due to pleural effusion while an obituary found online indicated the patient died on the same day as the surgery of complications of endocarditis.We do not have an operative report, so it is unclear whether or not the patient had a previous prosthetic valve, or valves, which became infected necessitating the on-x implants, or whether the endocarditis was related in some manner to the pleural effusion.The available evidence would suggest that infection is the primary cause of the patient death.Furthermore, since the patient died same day as surgery, the terminal infection would not have been introduced by the valves, having no time to flourish, and because on-x valves undergo a validated terminal sterilization process during manufacturing.If the patient had prior prosthetic valves, the historical record shows an occurrence rate of 1.2 %/patient-year for endocarditis for recipients of rigid heart valve substitutes [iso 5840:2005].Although the on-x valves are not the likely source of this infection, nevertheless, the instructions for use for the on-x valve acknowledge endocarditis as a risk factor in prosthetic valve replacement which may result in death [ifu].The risk of a surgical mortality for a mitral valve procedure has been reported as 5.74% for males [edwards 2001].The addition of aortic valve replacement and infection make the mortality rate worse still.We have no evidence of any on-x valvular malfunction by those listed above.The death of the patient is presumed to be related to infection and /or complications of surgical procedure.There is no indication that any of the on-x valves had any contribution to this outcome.No further action is required.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 cryolife is accurate or has been confirmed by cryolife.

• Brand Name: ONX MITRAL CONFORM 25/33
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9836597
• MDR Text Key: 183564394
• Report Number: 1649833-2020-00004
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/11/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR