MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number	9755RSL29A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	02/26/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for the same event.Reference related manufacturer report # 2015691-2026-13423.Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement (tvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to embolization of the device, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified leaflets, loss of pacing capture, a narrow sinotubular junction (in aortic position procedures), rapid deployment, the release of stored tension during deployment, inaccurate measurement of the landing zone, and movement of the delivery system by the operator.The ifu cautions that incorrect sizing of the landing zone may lead to paravalvular leak, migration, or embolization.The device training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valves (all models).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor in the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for embolization (i.E., minimal leaflet calcification, severe septal hypertrophy), balloon valvuloplasty may indicate potential balloon movement during valve deployment.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest procedural factors likely contributed to the event, including that the first sapien valve was malpositioned, which lead to the paravalvular leak and ultimately, embolization of both sapien valves.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a right-side transfemoral tmvr (transcatheter mitral valve replacement) procedure with a 29 mm sapien 3 ultra resilia (s3ur) valve in the native mitral position, there was a severe paravalvular leak (pvl) with an aortic pressure gradient-to-left ventricular of 30 mmhg post valve deployment.In response, the operating team performed an alcohol septal ablation and implanted an additional 29 mm s3ur valve.The pvl had reduced to mild and the patient was stable.It was noted that during the initial tmvr, a lampoon procedure was performed.In addition, this is an off-label case due to the native mitral position.The perceived root cause of the pvl was that the first valve was deployed too atrial.Additional information provided per fcs indicating the patient passed away.During the tavr procedure, two sapien valves were placed in the mitral position, and there was trace paravalvular leak noted.The following day, the sapien valves migrated into the left atrium and were freely mobile, which caused hemodynamic compromise and increasing oxygen requirements with evidence of end organ malperfusion.The patient also had severe mitral regurgitation.The care team offered surgical intervention, but the patient declined.The patient was subsequently placed on hospice care and later passed away.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
• 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: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24793521
• Report Number: 2015691-2026-13881
• Device Sequence Number: 8677357
• Product Code: NPU
• UDI-Device Identifier: 00690103215823
• UDI-Public: (01)00690103215823(17)280915(11)250916
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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: 9755RSL29A
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/06/2026
• 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: Death
• Patient Age: 85 YR
• Patient Sex: Female