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

Model Number 9600TFX29A

Device Problem Malposition of Device (2616)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 01/19/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Device remains implanted.

Event Description

As reported by the field specialist, during the off-label transfemoral transcatheter aortic valve replacement (tavr) procedure of a 29mm sapien 3 valve, the valve with an additional 6cc of volume embolized aortically during valve deployment.The valve was pulled back and secured in the descending aorta.The case was then aborted.The patient was noted to be stable and will be having another elective valve surgery.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The following sections of this report have been corrected/updated: h6 (health effect - impact code, health effect - clinical code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).Additional information was received revealing the patient had undergone another elective valve surgery in which the sapien 3 valve was explanted, and a surgical valve was implanted.The device was not returned to edwards lifesciences for evaluation.As a result, no visual inspection, functional testing, or dimensional analysis could be performed.In addition, no imagery was provided.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Per the ifu, the edwards sapien 3 valve is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis.The ifu warns that incorrect sizing of the valve may lead to events such as embolization.In addition, device embolization is listed as a potential risk associated with the valve, delivery system and/or accessories.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.Additional assessment of the failure mode is not required at this time.The event for valve embolizing into the aorta was unable to be confirmed.There was no allegation or indication a device malfunction contributed to this adverse event.A review of the ifu/training materials revealed no deficiencies.It should be noted that the transcatheter heart valve (thv) was implanted within an aortic insufficiency native valve (native annulus with no calcification).The sapien 3 (s3) with the commander delivery system (ds) was indicated for native aortic valve with severe native calcific aortic stenosis replacement.In this case, the transcatheter aortic valve replacement (tavr) procedure was being performed to treat severe aortic insufficiency.Therefore, this procedure was an off-label operation.Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to aortic embolization, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, the release of stored tension during deployment, and movement of the delivery system by the operator.As reported, "procedure of a 29mm sapien 3 valve, the valve with an additional 6cc of volume embolized aortically during valve deployment.Per case notes, the patient was being treated for severe aortic insufficiency (ai).The patient had an annulus of 780mm.Additional information was received indicating there were no allegations that the edwards device did not function as expected.The valve embolized as a result of the patient not having calcium to anchor the device.In addition, the large annulus further prevented proper placement." per the ifu, the size 29mm valve was recommended for a native valve annulus area ranging from 540 to 683 mm2.Therefore, a native annulus area of 780 mm2 was too large for the size 29mm sapien 3 valve.As a result, this could lead to valve embolization.In addition, the absence of calcification (aortic insufficiency) could prevent the deployed valve from properly anchoring onto the implant site (native annulus) resulting in valve embolization.In this case, available information suggests that procedural factors (valve size selection and off label operation) may have contributed to the reported event.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.No product risk assessment (pra) nor corrective or preventative actions are required.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• 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: 16352811
• MDR Text Key: 309287987
• Report Number: 2015691-2023-10727
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250816
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Device Catalogue Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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 Sex: Male