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

Model Number 9600TFX26

Device Problem Malposition of Device (2616)

Patient Problem Foreign Body Embolism (4439)

Event Date 01/04/2023

Event Type  Death  

Event Description

As reported by our edwards affiliate in france, a 26mm sapien 3 valve was deployed in the aortic position via the transfemoral approach.At the end of the valve deployment, the sapien 3 valve 'popped' and landed in a 10:90 aortic/ventricular (a/v) position.The decision was made to implant a second valve.During the preparation of the second sapien 3 valve, the initial valve embolized into the ventricle.A lasso was used to retract the valve out of the ventricle.The initial valve was deployed in the abdominal aorta.A vascular stent was also placed to stabile the valve and keep the leaflets open.A 29mm sapien 3 valve was then prepared and deployed with good results.The patient was transferred in stable condition but expired during the night after the procedure.The cause of death was not provided.It was speculated that a sizing error may have contributed to the valve embolization.

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

Update to b4, d9, g3, g6, h2, h6 (type of investigation, investigations findings, investigation conclusions) and h10 to reflect engineering evaluation.The 26mm sapien 3 valve was not returned to edwards for evaluation 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.Imaging was provided and revealed that the patient's annulus area measured 480.5mm, which is appropriate for the size 26mm thv (per ifu, 26mm thv is for annulus area between 430mm - 546mm).In addition, imaging found that the valve was fully expanded and appeared to deploy at target location and the deployed valve malpositioned was placed too ventricular.The commander delivery system with s3 ifu and procedural training manual were reviewed for guidance and instructions.The procedural training manual provides guidance on thv malposition and ventricular thv embolization.Thv malposition prior to deployment use caution with narrow calcified stj, minimal calcification and severe septal hypertrophy and mitral bioprosthesis.Ensure fluoroscopic view used for deployment is the coplanar view where inferior aspect of all 3 cusps are on same plane, consider coaxial alignment of catheter to the aortic annulus and if positioning is difficult using fluoroscopy alone, consider using both fluoroscopy and tee.Possible reasons for ventricular embolization include flex catheter not retracted preventing the balloon from fully inflating during thv deployment, thv inaccurately positioned too low (ventricular) and anatomical features (e.E.Narrow/calcified stj).Ventricular embolization management includes not removing the wire, maintain wire position and consider cpb and surgical intervention.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 malpositioned thv and thv embolized into ventricle were confirmed based on the provided imagery.There was no allegation or indication a device malfunction contributed to this adverse event.A review of ifu/training materials revealed no deficiencies.As reported, 'during procedure, the valve was deployed under rapid pacing and at the end of deployment, the valve 'popped' with a ventricular position (10/90), therefore, a second valve was needed.' based on review of the provided imagery and additional complaint activity, it was noted that the patient's annulus area was '480.5mm2 and it was normally calcified.' per the ifu, the 26mm valve is recommended for an annulus area with a range of 430-546 mm2, therefore, the 26mm valve used is appropriate for the patient's annulus size.There are several factors that may contribute to a malpositioned thv, including but not limited to: the flex catheter not retracted prior to deployment, build up tension, inadequate fluoroscopy view, narrow/calcified stj.As reported, 'by the time the second valve (29mm s3) was prepared, the 26mm s3 in place had fallen entirely into the ventricle.' per the (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement procedure.Additionally, a malpositioned valve is more susceptible to embolization.In this case, it is likely that the valve was not able to anchor properly on the target site (annulus) causing it to embolize into the ventricle.In this case, available information suggests that procedural factors (malpositioned thv) may have contributed to the thv embolizing into the ventricle.However, due to limited information, a conclusive root cause was unable to be determined for the report of malposition.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 is required at this time.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS 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: 16158180
• MDR Text Key: 307292216
• Report Number: 2015691-2023-10154
• Device Sequence Number: 1
• Product Code: NPT
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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; Death
• Patient Age: 87 YR
• Patient Sex: Female