MAUDE Adverse Event Report: EDWARDS LIFESCIENCES MITRIS RESILIA MITRAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11400M

Device Problem Fluid/Blood Leak (1250)

Patient Problems Arrhythmia (1721); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Through implant patient registry it was learned a 27mm 11400m mitral valve implanted in the tricuspid position was explanted at implant due to unknown reasons.Patient post-operative status noted as in recovery.Per medical records, through inspection of the right atrium, there was paucity of landmarks, marking determination of where exactly to place the new suture line difficult.A 27mm 11400m mitral valve was implanted in the tricuspid position and sutures secured with cor-knots.The cross-clamp was released, and complete heart block was noted.With limited ability to identify the anatomy, it was felt that atrioventricular block would be accepted and a permanent pacemaker would be required, which was highly likely regardless.The patient was weaned from cardiopulmonary bypass.Although the tricuspid valve was well seated and functioning appropriately, there was new moderate aortic insufficiency, and it was felt to be unacceptable result.The patient was noted to be complete atrioventricular block so a permanent pacemaker was implanted.Cardiopulmonary bypass was re-established.The 27mm 11400m mitral valve implanted in tricuspid position was explanted.Annular sutures were placed, taking care to place smaller sutures in the area of the left ventricle was ejecting, and on tee, the valve had returned its initial symmetric and there was no aortic insufficiency.A 27mm 11400m was implanted.On tying a few of the new valve sutures and relocating some of the sutures, the aortic caval tapes were unsnared, and ventilation was resumed.The patient was weaned from cardiopulmonary bypass.At this point, the aortic insufficiency was quite mild and, in fact, later on resolved completely.The patient was transferred to the cardiovascular intensive care unit.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional customer complaint.The information reported may or may not be related to the edwards device.

Manufacturer Narrative

Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Through implant patient registry and investigation, it was learned a 27mm 11400m mitral valve implanted in the tricuspid position was explanted at implant due to difficulty finding landmarks for the valve due to effacement of the annulus anatomy.Per medical records, the patient presented with a history of fungal native tricuspid endocarditis 16 months earlier.Due to the fungal component, it was felt tvr was likely to result in fungal prosthetic valve endocarditis, therefore the native tv excision was performed.The patient developed progressive shortness of breath and fatigability over the course of the next 16 months.She now appears to be a good candidate for redo surgery and placement of new tvr (abstained from iv drugs).Intraoperatively there was effacement of the normal architecture related to the prolonged absence of a valve.The features of the previous annulus were difficulty to identify.A 27mm 11400 mitral valve was ultimately implanted successfully but while weaning from bypass there was new aortic insufficiency.Cpb was re-established and the valve was removed; at this point the aortic valve regained its symmetry and there was no ai.On replacement of the prosthetic tv with new sutures there was recurrence of av insufficiency again.After adjusting the suture line several times there was only mild residual ai and the prosthetic tv was well-seated, functioning appropriately with no pvl.At the conclusion there was actually no residual ai as well.The patient developed complete heart block as expected and a ppm was implanted.The patient was transferred to the cv-icu and was discharged on pod #9.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18584984
• MDR Text Key: 333773800
• Report Number: 2015691-2024-00600
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female