MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Insufficient Information (3190)

Patient Problem Endocarditis (1834)

Event Date 04/16/2019

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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to initial reports, patient received a double valve replacement with onxae-23 sn (b)(4) implanted in the aortic position and onxmc-25/33 sn (b)(4) implanted in the mitral position (b)(6) 2019.The onxmc-25/33 sn (b)(4) was then explanted (b)(6) 2019 and replaced with another onxmc-25/33 sn (b)(4).This investigation is relegated to the onxmc-25/33 sn (b)(4).Cause for re-operation endocarditis.No additional information forthcoming.

Manufacturer Narrative

According to initial reports, the patient received a double valve replacement with onxae-23 sn (b)(6) implanted in the aortic position and onxmc-25/33 sn(b)(6) implanted in the mitral position (b)(6) 2019.The onxmc-25/33 sn (b)(6) was then explanted (b)(6) 2019 and replaced with another onxmc-25/33 sn (b)(6).This complaint is relegated to the onxmc-25/33 sn (b)(6).The cause for re-operation was "endocarditis".No additional information forthcoming.The manufacturing records for the onxmc-25/33 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.During the investigation no non-conformances or deviations were noted.A review of the available information was performed.Onxmc-25/33 sn (b)(6) was implanted in the mitral position of a 37-year-old male patient on (b)(6) 2019.On (b)(6) 2019 (237 days post-implant), this valve was explanted and replaced by onxmc 25/33 sn (b)(6) while the patient also received an onxae-23 sn (b)(6) in the aortic position thereby making it a double valve case.The reason for the explant and replacement was reported to the manufacturer by a representative of the surgeon as a consequence of endocarditis, i.E.Infection around the mitral valve.This typically has the effect of causing annulus tissue deterioration.Whether the endocarditis is the primary cause of the valve replacement or was a part of the decision at surgery to replace both aortic and mitral valves is not known.With the information available, the source and nature of the endocarditis is also unknown.However, because the on-x valve manufacture includes validated terminal sterilization prior to distribution, it is unlikely to be the source.The instructions for use for the on-x valve lists endocarditis as a possible complication of mechanical heart valve replacement and includes the possibility of reoperation and/or explantation [ifu].Historically, endocarditis occurs at a rate of 1.2 %/patient-year for rigid heart valves [iso 5840:2005).A definitive cause for the endocarditis cannot be ascertained from the information provided.However, infection resulting from the on-x valve is unlikely as it is terminally sterilized prior to distribution.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: ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9615907
• MDR Text Key: 176072399
• Report Number: 1649833-2020-00076
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/02/2020
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR