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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Additional manufacturer narrative: the device was not returned for evaluation.Attempts to retrieve the device and additional information are in process; 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 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.Edwards received notification that this a model 11400m29 was explanted after an unknown implant duration (however no greater than nine (9) days) for unknown reasons.
Event or Problem Description
Per response received, this valve model 11400m29 remained implanted.The information in ipr suggesting this valve was explanted was incorrect.Based on the information provided does not reasonably suggest there was a malfunction of the edwards device or that the use or improper use of the device caused or contributed to patient injury or death.Additionally, there was no allegation of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of this edwards device.Therefore, this event does not meet the criteria for a complaint as there is no device involved in this case.
Additional Manufacturer Narrative
Corrected information: b5: description.H11: additional manufacturer narrative.Initially, it was reported that this valve was explanted after an implant duration of 9 days for unknown reason.However the physician response suggested this valve was not explanted, and the information is not correct.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• 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 ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21950133
• Report Number: 2015691-2025-03455
• Device Sequence Number: 8799966
• Product Code: LWR
• UDI-Device Identifier: 00690103205558
• UDI-Public: (01)00690103205558(17)270823(11)230824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2023
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male