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

Model Number	9880DDSA
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	05/14/2026
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 notification of a sapien m3 procedure in the mitral position in which, during encircling around the medial commissure, a potential device-related wall perforation was suspected; although, there is no confirmation a perforation occurred at this time.The dock interacted with the septum, followed by a conduction system disturbance resulting in heart block.The patient had a mac score greater than 9, and dock troubleshooting may have contributed to interaction with the septum.During the procedure, the marker band was observed not moving with the distal tip, indicating potential loading.Due to the large volume of mac, the physician slightly unsleeved the dock.In conjunction with encircling maneuvers, this may have resulted in contact with the ventricular septal wall and contributed to the heart block.Intervention was required, including administration of atropine and epinephrine with subsequent temporary pacing.A temporary pacemaker was already in the patient.The clinical specialist was unsure whether a permanent pacemaker was implanted.The patients medical history included savr (23 mm) and laa clip.The procedure was completed successfully, with mitral regurgitation reduced from severe to none/trace.The patient remained stable; however, the ejection fraction (ef) decreased significantly.

• 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: 25340569
• Report Number: 2015691-2026-15671
• Device Sequence Number: 21364484
• Product Code: NPU
• UDI-Device Identifier: 00690103219760
• UDI-Public: (01)00690103219760(17)280224(11)260224
• 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): 07/13/2026

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: 05/14/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2026
• 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: 89 YR
• Patient Sex: Male
• Patient Weight: 72 KG