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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Event or Problem Description
Edwards received a report of a sapien m3 procedure in mitral position where there was a p3 mild pvl present that the team tried to interrogate with echo to determine if it was from the mc and making its way through the pvl guard or rather the posterior leaflet p3 area perforation that was a result of the failed teer performed on (b)(6)2026.They were not able to discern the exact location of the pvl but still decided to plug it.The plug resulted in none/trace pvl at the mc.The patient was doing well post procedure, and was discharged the next day.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.The complaint for intraprocedural paravalvular leak between dock and anatomy was confirmed based on empirical evidence.Available information in the complaint file suggests patient factors likely contributed to the event due to anatomical reasons, commissure to commissure distance and a perforation in the posterior leaflet.Therefore, the most likely cause of this event is due to patient factors.Based on the available information from the event description and engineering investigation, the root cause is likely due to patient factors.Potential patient factors such as large commissure to commissure distance and/or pre-existing commissural health conditions, such as leaflet cleft, perforation, prolapse, flail, and/or mac, may have influenced pvl outcome.This issue is not related to a device malfunction that is related to a manufacturing deficiency, labeling issue, or device related infection therefore a dhr is not required.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: 24225602
• Report Number: 2015691-2026-10693
• Device Sequence Number: 9366508
• Product Code: NPU
• UDI-Device Identifier: 00690103219760
• UDI-Public: (01)00690103219760(17)270916(11)250916
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/11/2026

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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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 Sex: Male