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

Model Number 9750TFX26A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2022

Event Type  Death  

Event Description

As reported by the field clinical specialist, during a transfemoral valve-in-valve procedure with a 26mm sapien 3 ultra valve in a mosaic valve in the mitral position, there was a challenging septum to cross the first s3u valve.The first s3u valve was damaged on the way out of esheath+ after trying to cross the septum.The team completed a septostomy with a 16mm balloon.A second s3u valve was able to cross the septum but embolized once deployed.The patient was taken to the or for a surgical repair.The patient did not survive the surgery.

Manufacturer Narrative

This supplemental is one of two reports being submitted for this case.Please reference manufacturer report number 2015691-2023-10169.The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Manufacturer Narrative

A supplemental mdr is being submitted due to new information received.

Event Description

As reported by the field clinical specialist, during a transfemoral valve-n-valve procedure with a 26mm sapien 3 ultra valve in a mosaic valve in the mitral position, there was a challenging septum to cross the first s3u valve.The first s3u valve was damaged on the way out of esheath+ after trying to cross the septum.The team completed a septostomy with a 16mm balloon.A second s3u valve was able to cross the septum but embolized once deployed.The patient was taken to the or for a surgical repair.The patient did not survive the surgery.Additional information was received, the first valve was brought back down to the esheath.A portion of the tip of the esheath caught in the inflow portion of the s3u when withdrawing but, ultimately, everything (sheath and delivery system with valve) was removed from the patient.The second valve was delivered over a wire "rail" through the septum, across the mitral valve into the left ventricle, through the aortic valve, up the ascending aorta and down the descending thoracic aorta.This provided the rigidity needed to cross the septum but resulted in some tension on the wire.This was performed successfully, and the septum was crossed with the delivery system and valve.The thv was advanced through the surgical mitral valve, positioned, and deployed.The second s3u valve held stable within the ventricular portion of the surgical valve stents for a few minutes and then became loose in the left ventricle for a few moments, it then repositioned itself within the ventricular posts of the surgical mitral valve while they took the patient to the or.The plan was to remove the embolized thv valve from the ventricle and place a surgical valve.During the repair a tear in the vena cava was discovered but could not be repaired.The patient did not survive the procedure.The perceived root cause of the tear in the vena cava is unknown but potentially from the forces used to cross the septum with the first or second delivery system and s3u.

Manufacturer Narrative

Corrected information in b.1 and b.2 as a correction to b.1 was made on the last follow-up report in error.This report remains submitted for an adverse event and death.Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned.An imaging evaluation was performed on the 3mensio imagery provided and there was no significant observation related to this complaint event.As no device was returned, engineering was unable to perform visual inspection, functional testing, or dimensional testing.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 this adverse event is not required at this time.The complaint was unable to be confirmed due to unavailability of procedural imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.Per the instructions for use (ifu), valve embolization is a known potential complication associated with the transcatheter heart valve replacement procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, minimally or bulky/severely calcified aortic leaflets, rapid deployment, release of stored tension during deployment, incorrect valve sizing, and movement of the delivery system by the operator.As reported, the valve was delivered over a wire "rail" through the septum, across the mitral valve into the left ventricle, through the aortic valve, up the ascending aorta and down the descending thoracic aorta.While it provided the rigidity needed to cross the septum, it resulted in some tension on the wire.It is possible that once the balloon was inflated, the tension in the wire pulled the delivery system towards ventricle resulting in valve embolization.As such available information suggests that procedural factors (tension in wire) may have contributed to the complaint event.However, a definitive root cause is unable to be determined.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 corrective or preventative actions are required.Since no device, labeling or ifu/training inadequacies were identified, no corrective/preventive action/supplier corrective action request nor product risk assessment escalation is required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• 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: 16162407
• MDR Text Key: 307454767
• Report Number: 2015691-2023-10182
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)231109
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• 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: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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; Death
• Patient Age: 68 YR
• Patient Sex: Female