MAUDE Adverse Event Report: EDWARDS LIFESCIENCES US SAPIEN 3 ULTRA VALVE, 26MM; PROSTHESIS, MITRAL VALVE PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

Device Problems Perivalvular Leak (1457); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Valve remains implanted in patient.

Event Description

As reported by an edwards field clinical specialist (fcs), the patient underwent an open surgical implant of a 26m sapien 3 ultra valve in the native mitral position.Post deployment the 1st valve appeared to be slightly atrial but stable, with mild paravalvular leak by echo.On post operative day 1 the patient was symptomatic and was found to have severe mitral regurgitation.It was noted that the valve had moved atrial with paravalvular leak (pvl).The first valve was poorly positioned, it was "rocking" and most likely would have embolized if not for the sutures in place.A mitral valve-in-valve procedure was performed, with a 2nd 26mm sapien 3 ultra was implanted on post operative day 2.

Manufacturer Narrative

Correction to b5 (describe event or problem).Update to h6 (device code, type of investigation, investigation findings, and investigation conclusions) and h10 to reflect engineer evaluation.The 26m sapien 3 ultra valve was not returned to edwards as it remains implanted in the patient.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.The commander delivery system with s3/s3u/s3ur ifu was reviewed for guidance and instructions.Potential adverse events include valve migration, malposition or embolization requiring intervention and valve regurgitation of paravalvular or transvalvular leak.No ifu/training deficiencies were identified.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 the failure mode is not required at this time.The complaints for thv migrated and paravalvular leak post implant were unable to be confirmed due to unavailability of relevant imagery/medical report.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.It should be noted that the thv was deployed within mitral annular calcification (mac) through surgical intervention (open heart surgery), which is not an indicated use of the device.Therefore, this was off-label operation.As reported, 'the patient underwent an open surgical implant of a 26m sapien 3 ultra valve in the native mitral position.On post operative day 1 it was noted that the valve moved atrial with paravalvular leak (pvl) requiring a 2nd 26mm sapien 3 ultra on post operative day 2.It was clarified that post deployment the 1st valve appeared to be slightly atrial but stable, with mild paravalvular leak by echo.' per additionally received information, 'the first valve was poorly positioned, it was 'rocking' probably would have embolized if not for the sutures in place.The pvl did not worsen after the 1st valve.' per the instructions for use (ifu), valve migration requiring intervention is a known potential adverse event associated with transcatheter valve replacement (thv).In this case, the valve was implanted via an open-heart surgery, which could have impacted the thv deployment characteristics, resulting in thv migration.Per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.In this case, due to the migrated thv, wherein the valve landed too atrial, it is likely that the thv skirt was unable to be properly seal against target site, resulting in paravalvular leak (pvl).In this case, available information suggests that procedural factors (thv migration and off-label operation) 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 labeling or ifu training inadequacies were identified.Therefore, no corrective or preventive actions nor product risk assessment are required.

Event Description

As reported by an edwards field clinical specialist (fcs), the patient underwent an off label open surgical implant of a 26m sapien 3 ultra valve in the native mitral position.

• Brand Name: US SAPIEN 3 ULTRA VALVE, 26MM
• 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: 15540175
• MDR Text Key: 301153426
• Report Number: 2015691-2022-08259
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)240901
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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 Sex: Female