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

Model Number	9600TFX23A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported from the medical records received, after the initial off-label transcatheter mitral valve replacement (tmvr) procedure with a 23 mm sapien 3 (s3) valve, the patient experienced an embolic cerebrovascular accident (cva).The exact date of the embolic cva was not provided.The patient was noted to be on warfarin (2.5 mg, five times weekly).No additional information was provided.
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.The device was used in off-label implantation in the mitral position.As there are no specific instructions for use (ifu) or training materials related to off-label mitral procedures, the available training materials were reviewed only for information potentially relevant to the device use.Per the instructions for use (ifu), permanent or transient neurological events such as transient ischemic attack (tia) and stroke are known potential adverse events associated with the overall transcatheter valve replacement (tvr) procedure and the use of the edwards transcatheter heart valve (thv) devices.According to the literature review, and as documented in a clinical technical summary written by edwards lifesciences, stroke is recognized in the literature as a well-known complication in a small number of patients undergoing thv.Risk factors correlating with several patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during thv are undoubtedly multifactorial, the dominant etiology likely being intraprocedure embolic events.A transcranial doppler study during thv demonstrated that most procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early post-procedure stroke: female sex, ejection fraction (ef) less than 30%, diabetes, age older than 70 years, bypass procedure time greater than 120 minutes, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no significant differences in the frequency of late strokes between thv and aortic valve replacement (avr) patients.After thv, there appears to be a more considerable proportion of early strokes occurring less than 24 hours post-procedure, but thv patients with multiple co-morbidities are probably at higher risk of both early and late strokes.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Due to limited information, a definitive root cause was unable to be determined; however, the event could be related to the mechanisms described above.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.

• Brand Name: SAPIEN 3 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: 25083512
• Report Number: 2015691-2026-14938
• Device Sequence Number: 10574578
• Product Code: NPU
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)200714
• 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: 2018
• 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): 05/05/2026

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 Expiration Date: 07/14/2020
• Device Model Number: 9600TFX23A
• 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: 04/10/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2018
• 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: Disability
• Patient Age: 81 YR
• Patient Sex: Female