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

Model Number 9600TFX29A

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The valve remains implanted in the patient.

Event Description

As reported by an edward's territory manager, approximately 2 years and 9 months post implant of a 29mm sapien 3 valve implanted inside an edwards surgical mitral valve, the patient presented with two of the three leaflets no longer functioning due to hypoattenuated leaflet thickening (halt).It appeared that the inflow of the sapien 3 was under-expanded and had an apparent diameter in the vicinity of 26mm sized valve.After access and crossing of the valve with a guidewire, the 29mm sapien 3 valve in mitral position was re-dilated with a 28mm non-edwards balloon valvuloplasty catheter to approximately 12-14 atmospheres.After dilation, the inflow of the valve was visually larger.A new 29mm sapien 3 was implanted within the original sapien 3 valve (valve-in-valve-in-valve).There were no issues presented during the implant.After implant, the sapien 3 valve in mitral position appeared to be securely implanted, performed as designed, and the mitral mean gradient went from 10mmhg to 2mmhg with no paravalvular leak (pvl) by echocardiogram.The delivery system and sheath were removed.The patient was stable and transferred for post management care.There was no left atrial thrombus noted at the time of the procedure.

Event Description

Updated information was provided.Of note, at the time of implant the 1st sapien 3 mitral valve was deployed with nominal volume in a 90:10 implant position inside a 27mm perimount mitral surgical valve.In addition, during the same procedure, the patient had a 23mm sapien 3 implanted within a failed surgical valve in the aortic position.It was confirmed that there were no issues associated with the aortic sapien 3 implanted in 2019.

Manufacturer Narrative

(type of investigation, investigation findings and investigation conclusions) and h10 to reflect engineering evaluation.The 29mm sapien 3 valve was not returned to edwards lifesciences for evaluation as it remains implanted in the patient.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A device history records (dhr) review did not reveal any issues that could have contributed to the reported events.The commander delivery system ifu was reviewed for guidance and instructions.Potential adverse events include structural valve deterioration (thickening).No ifu or training 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 complaints for leaflet thickened/halt was unable to be confirm as relevant imagery and/or medical record.A review of dhr did not identify any manufacturing non-conformities that would have contributed to the reported event.Additionally, no ifu/training manual inadequacies were identified.As reported, 'approximately 2 years and 9 months post implant of a sapien 3 valve implanted in the mitral position inside a surgical valve, the patient presented with two of the three leaflets no longer functioning due to halt'.Additionally, it was reported that a new 29mm sapien 3 was implanted within the original sapien 3 valve.'there were no issues presented during the implant.There was no left atrial thrombus noted at the time of the procedure.' per the instructions for use (ifu), structural valve deterioration (leaflet thickening) is potential risk associated with the use of the transcatheter heart valves (thv).There are patient factors that can lead to leaflet thickening.Thrombosis can resemble leaflet thickening and impact leaflet functionality.However, in this case, it was reported that the there was no thrombus noted at the time of the procedure.In this case, it is possible that patient factors (hyperlipidemia) may have contributed to the reported event.The patient has a past medical history of hyperlipidemia, which is a well-known risk factor for calcification.Leaflet calcification leads to leaflet thickening.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 labeling or ifu training inadequacies were identified.Therefore, no corrective or preventive actions nor product risk assessment are required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• 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: 15350161
• MDR Text Key: 299188864
• Report Number: 2015691-2022-07676
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)210402
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2021
• 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: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• 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