MAUDE Adverse Event Report: EDWARDS LIFESCIENCIES EDWARDS SAPIEN 3 ULTRA VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX23A

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

The valve was not returned for evaluation.Investigation is ongoing.

Event Description

As reported by field clinical specialist, 23mm sapien 3 ultra (s3u) valve was being implanted for aortic insufficiency (ai).The valve was deployed without issue.The team was getting ready to remove the tee probe and noticed that the valve had migrated into the left ventricular outflow tract (lvot).The physician got access again and in the process of attempting to cross the valve, the s3u popped out into the left ventricle.They put the patient on pump and they decided to open the patient.The s3u was removed and a surgical valve was implanted.

Manufacturer Narrative

Update to h6 type of investigations, investigation findings and investigation conclusions added and h10 per no product investigation completion.As no device was returned for evaluation, no visual inspection, functional testing or dimensional testing could be performed.Imagery was reviewed.Annular area and average diameter measured at 328.8 mm2 and 20.6 mm, respectively, indicative of an over-sized 23mm thv, likely implanted to facilitate a better grip against the calcium-free annulus.No calcium deposits were noted on the annulus, which appeared to be somewhat irregular in shape.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.Therefore, no device history review and lot history review was required.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.It should be noted that the thv was deployed in native aortic position to treat aortic insufficiency.Review of provided imagery revealed no indication of annular calcification but disclosed small annular dimensions relative to thv sizing election (implantation of an over-sized thv can be used to over-compensate for the absence of calcium through improved gripping forces).Based on this information, it is likely that the thv was implanted in a calcium-free landing zone.The sapien 3 ultra (s3u) thv with the commander delivery system (ds) is currently only indicated for valve replacement involving native calcific aortic stenosis as well as replacement of a failing surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring.Therefore, this was off-label operation.The ifu and training manuals in this section are for tf (transfemoral) procedure in aortic/mitral position and were reviewed for relevant guidance for an s3 implant using a commander ds.No ifu/training deficiencies were identified.Implantation of thv in a non-calcified native aortic annulus using the sapien 3 ultra (s3u) valve with the commander delivery system (ds) is not an indicated use of the device.The risk management file captures risks for indicated device use only.The review of the risk management file is completed, and no further action is required at this time.The migration and embolization were unable to be confirmed due to unavailability of medical record/applicable imagery.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 implanted within non-calcified native aortic annulus, which is not an indicated use of the sapien 3 ultra thv with the commander delivery system.Therefore, this was off-label operation.As reported, ''valve being implanted for ai - valve was deployed, closed & in the final stages of the procedure.Getting ready to remove tee prob & noticed that the valve had migrate into the lvot.Physician got access again & in the process of attempting to cross the valve it popped out into the lv''.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, review of provided 3mensio revealed that patient lacked annular calcium, which is needed to provide secure anchoring for the valve.Despite deployment of an over-sized thv (as a likely attempt to enhance the gripping force), it is possible that the forces acting on the thv overcame the strength of valve attachment due to the absence of calcification, causing the thv to dislodge and move towards the ventricle.As such, available information suggests that procedural factors (off-label operation) may have contributed to the complaint event.Per the instructions for use (ifu), valve embolization is a known potential complication associated with the transcatheter aortic valve replacement (tavr) procedure.In this case, the thv migrated towards the ventricle due to lack of calcium, which would have led to further weakened attachment forces against the annulus.Subsequent manipulations by the physician, while attempting to cross the loosely attached valve, likely caused it to embolize into the ventricle as a result of the compromised anchoring.As such available information suggests that procedural factors (thv migrated) may have contributed to the complaint event.Since no device problem was identified affecting distributed product, no pra is required.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions are required.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS SAPIEN 3 ULTRA VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCIES; 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: 16397463
• MDR Text Key: 309772729
• Report Number: 2015691-2023-10918
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)250803
• 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
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX23A
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• Is the Device Single Use?: No
• 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