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

Model Number 9600TFX29A

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2022

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 29 mm sapien 3 (s3) valve in the mitral position via transapical approach, the first valve was placed in native mitral space as planned with +5cc from nominal.Tee and fluoro showed that the valve was migrating in the atrial post implant.A second 29mm s3 was placed in a more ventricular position in an attempt to anchor both prosthesis.The tee and fluoro both showed that the 2 valves were migrating in the atrial direction.Patient was placed on ecmo and taken for emergency room for open heart surgery.Both 29mm sapien valves were explanted and a surgical mitral valve was implanted.

Manufacturer Narrative

This is two of two manufacturer reports being submitted for this case.Please reference 2015691-2022-07556 manufacturer report.Device not returned.

Manufacturer Narrative

This is 2 of 2 manufacturer reports being submitted for this case.Please reference related manufacturer report no:2015691-2022-07556.A supplemental mdr is being submitted for correction and additional information base on the device evaluation.The sapien 3 valve was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.All inspections are conducted on 100% of the units.Per procedure, the sapien 3 valve is visually and dimensionally inspected for defects.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The instructions were reviewed instruction for use (ifu) for commander delivery system with s3, procedural training manual and no ifu/training deficiencies were identified.The complaint was unable to be confirmed due to unavailability of applicable imagery/medical record.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.It should be noted that the thv was deployed within thv at mitral position, which is not an indicated use of the device.Therefore, this was off-label operation.As reported, "the first valve was placed in native mitral space as planned with +5cc from nominal.Tee and fluoro showed that the valve was migrating in the atrial post implant", "a second 29mm s3 was placed in a more ventricular position in an attempt to anchor both prostheses.The tee and fluoro both showed that the 2 valves were migrating in the atrial direction" and "both 29mm sapien valves were explanted and a surgical mitral valve was implanted".Per additionally received information, "the cause of the migration was the valve being undersized to the native mitral anatomy." 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.In this case, the second thv was implanted inside a potential undersized thv (first implanted valve), which likely prevented secure anchoring of the valve to target site, causing both valves to migrate atrial post-deployment.As such, available information suggests that procedural factors (undersized valve, off label operation) may have contributed to the complaint event.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) escalation or a corrective preventative action (capa) is not required.

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 29 mm sapien 3 (s3) valve in mac (mitral annular calcification) in the mitral position via transapical approach, the first valve was placed in native mitral space as planned with +5cc from nominal.Tee and fluoro showed that the valve was migrating in the atrial post implant.A second 29mm s3 was placed in a more ventricular position in an attempt to anchor both prosthesis.The tee and fluoro both showed that the 2 valves were migrating in the atrial direction.Patient was placed on ecmo and taken for emergency room for open heart surgery.Both 29mm sapien valves were explanted and a surgical mitral valve was implanted.

• 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: 15312057
• MDR Text Key: 298801681
• Report Number: 2015691-2022-07557
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250523
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model 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: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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: Female