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

Model Number 9600TFX26

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/30/2022

Event Type  Injury  

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.The investigation is ongoing.Device remains implanted.

Event Description

As reported by our affiliates in france, during the transfemoral transcatheter aortic valve replacement (tavr) procedure of a 26mm sapien 3 valve, the valve embolized into the ascending aorta.It was noted that the valve was fully deployed.A decision was made to implant a 29mm sapien 3 valve.The valve was implanted successfully with satisfactory results.There was no patient injury.

Manufacturer Narrative

A supplemental mdr is being submitted to include additional information.This is one of three manufacturer reports being submitted for this case.Please reference manufacturer report numbers: 2015691-2023-10762 and 2015691-2023-10763.The investigation is still ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The device was not returned to edwards lifesciences for evaluation.As a result, no visual inspection, functional testing, or dimensional analysis could be performed.Records were provided for review.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Per the ifu, valve embolization requiring intervention is listed as a potential risk associated with the transcatheter aortic valve replacement (tavr) procedure, the bioprosthesis, and the use of its associated devices and accessories.The ifu/training manuals also provides the nominal inflation volume for the size of the valve being implanted and warns that correct sizing of the transcatheter heart valve (thv) is essential to minimize the risk of events such as migration.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.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 event for valve embolizing into the aorta was confirmed based on the records provided.A review of the complaint history did not provide any indication that a manufacturing non-conformance contributed to the event.A review of the ifu/training materials revealed no deficiencies.As reported, "during the procedure, the valve migrated to the ascending aorta.As per information received, the event is related to a lack of push on the guiding." 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.It was noted that 17ml of inflation fluid volume was used during deployment.Per the ifu, a 23ml inflation volume should be used for a 26mm valve and delivery system.In addition, a larger valve (29mm) was used for the second deployment.In this case, it was likely either the valve was under expanded or was undersized, which could lead to the deployed valve improperly anchoring onto the target site (native annulus), resulting in valve embolization into the aorta.In this case, available information suggests that procedural factors (under expanded valve and undersized valve) 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: 16363699
• MDR Text Key: 309405060
• Report Number: 2015691-2023-10761
• 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,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• 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: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 74 KG