MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS 23F GUIDE SHEATH; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number	9880GSA
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Edwards received a report of a sapien m3 procedure in the mitral position in which an aneurysmal septum required lateral advancement of the guide sheath (gs) to gain left atrial (la) access.The gs appeared clear of tissue on 3d tee; however, embolization of air was observed due to the gs pulling against the lateral wall during gs aspiration and flushing.The air was noted after introduction of the gs into the left atrium and during subsequent guide sheath and dock steerable catheter (dsc) manipulation, approximately mid-procedure.Additional information was subsequently received from the field, during initial gs insertion, aspiration resulted in air and some blood while the wire and introducer were positioned across the gs seals.The first gs was removed and re-prepped.The interatrial septum was ballooned, and the gs was reinserted across the septum.When the reinserted gs was flushed and aspirated during wire and introducer removal, only air was obtained.The gs was then removed and exchanged for a second gs that was positioned laterally.During aspiration of the second gs associated with wire and introducer removal, blood was obtained; however, some air ingress was observed, and the septal wall was noted to be suctioned into the gs.When inserting the dock steerable catheter (dsc) across the gs seals, only blood was aspirated; however, the septum was still observed being suctioned.Shortly thereafter, bubbles were observed, and transient right coronary artery (rca) occlusion was noted on fluoroscopy, with a brief decrease in right ventricular function reported.The procedure continued following resolution of this observation.
Additional Manufacturer Narrative
Health effect, impact code not available in dropdown: f11 non-serious injury/illness/impairment.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: EDWARDS 23F GUIDE SHEATH
• 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: 24955105
• Report Number: 2015691-2026-14584
• Device Sequence Number: 5280188
• Product Code: NPU
• UDI-Device Identifier: 00690103219784
• UDI-Public: (01)00690103219784(17)271014(11)251014
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P250019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9880GSA
• Device Lot Number: 67393366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Male