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

Model Number 9750TFX26A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cardiogenic Shock (2262); Insufficient Information (4580)

Event Date 06/28/2022

Event Type  Death  

Event Description

As reported by the field clinical specialist (fcs), during an off label 26mm sapien 3 ultra valve in mac procedure, it was decided to perform an off-label 'double barrel gun' technique in which two valves were simultaneously implanted via double trans-septal punctures and two physicians implanted 2 valves at the same time in the native mitral position side by side.Although both valves were implanted where the physicians intended, post implant, both valves were noticed to have been implanted too atrium or and could been seen migrating into the left atrium.It was decided to perform a valve in valve (vinv) procedure with two 26mm sapien 3 ultra valve's to prevent the previously implanted valves from completely embolizing.However, post implant, the valves were unstable and eventually embolized into the left atrium.The case was converted to open surgery, and a soft ring was placed surgically and a 29mm sapien 3 valve was placed in the ring.The patient was removed from the pump and sent to icu with stable vitals.Approximately 3 days later, the patient's valve slightly moved causing paravalvular leak (pvl).It was decided to added another 29mm sapien 3 valve with 3ccs.The patient's native mitral valve was heavily calcified and was kidney shaped in appearance and very large.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

Imagery provided by the facility was reviewed and the following was observed: two side-by-side valves appeared to be deployed simultaneously.Two valve-in-valve configurations appeared to be rocking, indicating that they were not properly secured to target location or embolized.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.The complaint for thv migrated was unable to be confirmed based on provided imagery/medical record.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.It should be noted that the thv was deployed within mitral annular calcification (mac), alongside another thv in a dual implant procedure, which is not an indicated use of the device.Therefore, this was off-label operation.As reported, 'it was decided to perform an off-label 'double barrel gun' technique in which two valves were simultaneously implanted via double trans-septal punctures' and 'post implant, both valves were noticed to have been implanted too atrium or and could been seen migrating into the left atrium.' per the instructions for use (ifu), valve migration requiring intervention is a known potential adverse event associated with transcatheter valve replacement (thv).According to the literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the annulus.Review of medical records revealed an oversized and kidney shaped native annulus capable of accommodating two 26 mm s3u valves.It is likely that the deployed thv structure was unable to securely anchor to adjacent valve and/or to noncircular annulus, resulting in migration.As such available information suggests that procedural factors (off-label operation) and/or patient factors (kidney-shaped annulus) may have contributed to the complaint event.The complaint for thv embolized into atrium was confirmed based on provided imagery.A review of complaint history did not identify any manufacturing non-conformances that would have contributed to the reported event.Additionally, no ifu/training manual inadequacies were identified.As reported, 'it was decided to perform a valve in valve (viv) procedure with two 26mm sapien 3 ultra valve's to prevent the previously implanted valves from completely embolizing.However, post implant, the valves were unstable and eventually embolized into the left atrium.' per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.In this case, the thv was not properly secured against mitral annulus, which caused it to embolize during valve-in-valve due to additional manipulation.As such, available information suggests that procedural factors (off-label operation, device manipulation ) may have contributed to the complaint event.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.

Event Description

It was initially reported by the field clinical specialist (fcs), during an off label 26mm sapien 3 ultra valve in mac procedure, it was decided to perform an off-label 'double barrel gun' technique in which two valves were simultaneously implanted via double trans-septal punctures and two physicians implanted 2 valves at the same time in the native mitral position side by side.Although both valves were implanted where the physicians intended, post implant, both valves were noticed to have been implanted too atrium or and could been seen migrating into the left atrium.It was decided to perform a valve in valve (vinv) procedure with two 26mm sapien 3 ultra valve's to prevent the previously implanted valves from completely embolizing.However, post implant, the valves were unstable and eventually embolized into the left atrium.The case was converted to open surgery, and a soft ring was placed surgically and a 29mm sapien 3 valve was placed in the ring.The patient was removed from the pump and sent to icu with stable vitals.Approximately 3 days later, the patient's valve slightly moved causing paravalvular leak (pvl).It was decided to added another 29mm sapien 3 valve with 3ccs.The patient's native mitral valve was heavily calcified and was kidney shaped in appearance and very large.However, per medical records review, the patient was on pressors and cardiac insufficiency progressed to cardiogenic shock by post operative day (pod) 2.Tee report done on pod 3 showed worsening mitral regurgitation.The patient was taken to the or and was placed on va ecmo for cardiogenic shock, and lacerations in both commissures from prior attempted tmvr were noted.A ring was sutured in several places around the underside of the mac, and an s3u 29mm valve was deployed into an mc3 ring.Several areas of pvl were treated with occluders in the anteromedial region.The mr at the end of the procedure was ~ 2+ paravalvular with contained distal migration of the devices.The patent tolerated the procedure well, with no immediate complications.The patient was placed on comfort care measures and withdrawal of ecmo support.A dnr order was enacted, and the patient passed away approximately 7 days post initial valve procedure.

Manufacturer Narrative

Upon further review prior to closure, it was noticed that health effect - clinical code in h6 was incorrect.G4 date reflects the date this error was detected.Additionally, please note that this is 1 of 4 manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-06976, 2015691-2022-06978, and 2015691-2022-06979.

• Brand Name: EDWARDS SAPIEN 3 ULTRA 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: 15089363
• MDR Text Key: 296466211
• Report Number: 2015691-2022-06975
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250316
• 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,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death
• Patient Sex: Male