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

Model Number	11400M33MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
Through implant patient registry it was learned that a 33mm 11400m mitral valve explanted after an implant duration of 4 months, 18 days due to unknown reason.The explanted mitral valve was replaced with another 33mm 11400m valve.During the same procedure the patient also had a 29mm 11500a aortic valve was explanted after an implant duration of 4 months, 18 days due to unknown reason (2023-17418-01).The explanted aortic valve was replaced with a 27mm 11500a valve.
Additional Manufacturer Narrative
Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
Through implant patient registry and medical records, it was learned that a 33mm 11400m mitral valve explanted after an implant duration of 4 months, 18 days due to endocarditis.The explanted mitral valve was replaced with another 33mm 11400m valve.Per medical records, the patient presented with sob.The patient underwent redo-avr with a 27mm inspiris (b)(4), redo-mvr with a 33mm 11400m mitris valve, and ecmo placement.Intraoperatively, mitral valve prosthesis was dehisced with infectious destruction of the aorto-mitral curtain and vegetations on the prosthetic aortic valve.Unable to adequately debride and replace the mitral valve with the av in place, both were removed.The aorto-mitral curtain had torn suture causing massive pvl and valve rocking.The aorto-mitral curtain was repaired.A new 33mm mitris valve and 27mm inspiris valve were implanted.The patient was transferred to icu in critical but stable condition.

• Brand Name: EDWARDS MITRIS RESILIA MITRAL VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17605427
• Report Number: 2015691-2023-15423
• Device Sequence Number: 6206402
• Product Code: LWR
• UDI-Device Identifier: 00690103205572
• UDI-Public: (01)00690103205572(17)240817(11)220818219799836
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: 11400M33MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male