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

Model Number 11400M29

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.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

Edwards received information that a 29mm 11400m mitral pericardial valve was explanted at six (6) days after the implant surgery due to mitral regurgitation secondary to suture looping caused by technical issue.At the implant surgery, the device was implanted with a non-everting mattress technique.After sliding the valve down into the patient mitral annulus, the surgeon took the unusual procedure of removing the entire holder before knotting the sutures, which was done because of the poor operative field due to the patient anatomy.After the valve implant, intraoperative echo showed transvalvular regurgitation, however, later it was confirmed that the regurgitation disappeared, so the patient chest was closed.During the postoperative follow-ups, moderate to severe mitral regurgitation was observed and the decision was made for reoperation.The ascending aorta was incised, and the device was checked over the aortic valve, and it was confirmed that suture looping had occurred at the post of the posteromedial commissure.The device was explanted and replaced with a smaller size same model 27mm 11400m valve.The patient was reported as under treatment in the icu due to severe pulmonary hypertension the patient had preoperatively, and postoperative intubation problems, renal dysfunction, and liver dysfunction.The device was not returned for evaluation as it was discarded at the hospital.There was no allegation of device malfunction.According to the surgeon, the patient was quite large, and the distance from the chest wall to the mitral valve made visibility of the operative field difficult.The device was originally implanted for mitral valve replacement and tricuspid annuloplasty was simultaneously performed.Information of the patient medical history was not provided by the surgeon.

Manufacturer Narrative

The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Per the description of event, edwards received information that a 29mm 11400m mitral pericardial valve was explanted at six (6) days after the implant surgery due to mitral regurgitation secondary to suture looping caused by technical issue.Dhr review was performed and no relevant nonconformances were identified.The most likely cause is suture looping due to use error.

• Brand Name: EDWARDS LIFESCIENCES MITRIS RESILIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15785208
• MDR Text Key: 303557970
• Report Number: 2015691-2022-09229
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048/S047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

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: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: 11400M29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening