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

Model Number 9600TFX29A

Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

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

Event Date 03/25/2022

Event Type  Death  

Event Description

Per the field clinical specialist (fcs), during an off-label mitral valve-in-mitral annular calcification (mac) case using a 29mm sapien 3 valve via transapical approach, after the first valve was implanted, paravalvular leak (pvl) was noted.A plug was inserted but the pvl was still seen.A second valve was implanted but the pvl remained and upon trying to close the pvl, the catheter accidentally dislodged both valves.Another 29mm s3 was emergently implanted successfully.The two conjoined sapien valves were then pinned to the atrial septum by a septal closure device.It was later communicated that the patient expired from an unknown cause three days post implant.There are no additional details this time.

Manufacturer Narrative

Investigation is ongoing.Please note that medwatch 2015691-2022-05363 for the first valve was submitted and related to this event.Valve remains implanted.

Manufacturer Narrative

Update to h6; type of investigation, investigation findings, investigation conclusion.The sapien 3 valve was not returned to edwards lifesciences for evaluation; therefore, no visual inspection, functional testing and dimensional testing is applicable.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u.It should be noted that it was a valve in valve procedure.The sapien 3 transcatheter heart valve (thv) (s3) with the commander delivery system (ds) is currently indicated for native aortic valve, surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring replacement.In this case, the valve was used in an off-label operation.The ifu and training manuals in this section are for a tf procedure in the aortic/mitral position for relevant guidance for an s3 implant using a commander ds.Based on this review, no ifu training deficiencies were identified.The transcatheter heart valve (thv) in thv replacement using the sapien 3 (s3) with the commander delivery system (ds) in the mitral position is not an indicated use at the time of implant.The risk management file captures risks for indicated device use only.The review of the risk management file is complete, and no further action is required at this time.The complaints for embolization and interventional device interact with pre-existing implantable device were confirmed based on medical record provided.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu and training manuals revealed no deficiencies.As reported, "a second valve was implanted but the paravalvular leak (pvl) remained and upon trying to close the pvl, the catheter accidentally dislodged both valves" and "this improved, another plug was attempted on a second leak (pvl) however the advancement of the non-ew (gore) sheath embolized the 2 valves." available information suggests that procedural factor (off label operation resulting in pvl and non-edwards sheath interacting with pre-existing deployed (thv) may have contributed to the complaint event.In this case due to the paravalvular leak after the second valve deployment, led to the non-edwards (gore dryseal sheath) interacting with the pre-existing deployed valves.If excessive manipulation was applied, it could lead to dislodgment of the valves and embolization from the target location.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.

Manufacturer Narrative

Per medical record review a supplement report is being submitted.Update to b2 (death), b5 (event description) b7 (relevant medical history), h1 (type of reportable event, h6 impact code, device code and clinical code.

Event Description

Per medical record review, the operative note stated the patient presented with acute on chronic (congestive heart failure) chf.The patient underwent a lampoon procedure on the anterior leaflet followed by a transcatheter mitral valve replacement with sapien 3 "augmented with gore-tex".Post deployment there was significant leak, and a plug was implanted for the paravalvular leak (pvl).The decision was to deploy a 2nd valve which would help with "the girth of the first valve than to flare it." this improved, another plug was attempted on a second leak (pvl) however the advancement of the non-ew sheath embolized the 2 valves.Cpr was initiated and a 3rd valve was prepped urgently and deployed.The operators 'pined' the valves to the septum with a 38mm aso (atrial septal occluder).An embolized plug in the leg was retrieved percutaneously.Another plug embolized to the pulmonary arteries and was patent without any significant limitations of flow.Post procedure, the patient was on an intra-aortic balloon pump (iabp) with significant pressor medications with a stable blood pressure and the patient was transferred to the unit in stable but critical condition.The primary cause of death was related to cardiogenic shock secondary to transcatheter mitral valve procedure and aortic valve disease.

• Brand Name: 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: 14190113
• MDR Text Key: 289976526
• Report Number: 2015691-2022-05367
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)230604
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• 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: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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): Death; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female