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

Model Number 9600TFX26

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Event Description

As reported, it was a valve in valve case of a 26mm sapien 3 valve, in mitral position into a non-edwards surgical valve, by transeptal approach.During procedure, it was not possible to cross septum with the commander delivery system with the valve due to the transeptal hole was too high and the angle was too difficult for the delivery system to cross.Therefore, a new kit was prepared and a new transeptal hole was performed.The valve was implanted but there was severe mitral regurgitation due to low implantation.Therefore, another valve was successfully implanted.The patient was in stable condition post-procedure.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 device codes and type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were unable to be confirmed due to unavailable relevant medical record and imagery.There was no allegation a device malfunction contributed to this adverse event.A review of ifu/training materials revealed no deficiencies.As reported, ''the valve was implanted but there was severe mitral regurgitation due to low implantation''.Malposition per the instructions for use (ifu), valve malposition requiring intervention is a known potential adverse event associated with the transcatheter heart valve replacement procedure.Per training manual, ''align the outflow of crimped sapien 3 valve 2mm below (towards ventricles) the surgical valve outflow markers'', and ''final sapien 3 valve implant depth should be targeted no more than 20% (atrial) for optimal valve function''.In this case, the valve was deployed at 0:100 a/v position, which may be too low for proper valve function.Paravalvular leak per the instructions for use (ifu), paravalvular leak is a potential adverse event associated with bioprosthetic heart valves and the transcatheter heart valve replacement procedure.In this case, it was likely the low valve deployment leading to the improper seal against the target site, resulting in paravalvular leak.As such, available information suggests that procedural factors (malposition, valve positioning and deployment technique) may have contributed to the complaint event.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: 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: 16397223
• MDR Text Key: 309758092
• Report Number: 2015691-2023-10911
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR