MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN M3 DOCK STEERABLE CATHETER; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number	9880DDSA
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Edwards received a report of a sapien m3 procedure in mitral position where one week post procedure the patient returned to the hospital having congestive heart failure symptoms and it was found that there was severe pvl in the medical commissure.The patient was hospitalized and on pod 19 the pvl was plugged and was resolved.Immediately post procedure there was only mild pvl and patient was doing well.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.Additional type of investigation codes that were unable to be added in h6: labelling review.The complaint for post procedural paravalvular leak between dock and anatomy was confirmed empirically through the complaint file.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.The pvl grade was reported to be mild at the medial commissure post index procedure.Available information in the complaint file suggests patient factors likely contributed to the event due to anatomical reasons, commissure to commissure distance and prolapse.Therefore, the most likely cause of this event is due to patient factors.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.Since there are no confirmed product or labeling/ifu/training material non-conformances affecting distributed product and no other triggers have been met, no preventative or corrective actions are required.

• Brand Name: SAPIEN M3 DOCK STEERABLE CATHETER
• Common Device Name: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 24791334
• Report Number: 2015691-2026-13858
• Device Sequence Number: 15654862
• Product Code: NPU
• UDI-Device Identifier: 00690103219760
• UDI-Public: (01)00690103219760(17)271021(11)251021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P250019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 9880DDSA
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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
• Patient Age: 80 YR
• Patient Sex: Male