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

Model Number	11400M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards lifesciences maintains an implant patient registry (ipr).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.It was reported via the implant patient registry that this mitris resilia valve model 11400m25 implanted in the mitral position was explanted from a 62-year-old patient after an implant duration of two (2) months and sixteen (16) days for unknown reason.A 29mm surgical valve was implanted in replacement.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: due diligence attempts were made to gather additional information regarding a device failure mode, however additional information is not available at this time.Patient medical records were not provided by the hospital for review, or the medical records provided do not clarify the device failure mode.The device was not returned for evaluation.Per the instructions for use (ifu), reoperation/explant are known potential adverse events associated with bioprosthetic cardiac valves and annuloplasty rings.In this case, there is no evidence of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.Based on the information available, a definitive root cause cannot be conclusively determined.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Common Device Name: 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19573117
• Report Number: 2015691-2024-04732
• Device Sequence Number: 12892996
• Product Code: LWR
• UDI-Device Identifier: 00690103205534
• UDI-Public: (01)00690103205534(17)240203(11)220203
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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 Expiration Date: 02/03/2024
• Device Model Number: 11400M
• 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: 06/01/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2022
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female