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

Model Number 9600TFX29A

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

Edwards received notification from a field clinical specialist that a patient with a 29mm sapien 3 placed in mitral annular calcification (mac) for 9 months was admitted to the hospital with persistent elevated transcatheter mitral valve gradient.A post dilation was performed and the patient was sent to rehab.Per medical records review, the patient was admitted with acute-on-chronic heart failure due to multiple valvular disease.A cardiac catheterization study was done for evaluation and reported severe transcatheter mitral valve stenosis with mitral mean gradient of 14 mmhg.A tte done on the same date reported severe motion restriction (almost immobility) of one of the mitral thv leaflets resulting in severe mitral stenosis.There was also moderate-severe mitral perivalvular leak (pvl).The patient is also status post tavr with a 26mm sapien 3 valve implanted in aortic position, the aortic valve was reported to have normal function and mild pvl.A mitral balloon valvuloplasty was performed with a 28mm true balloon x 2.Tee demonstrated less but still residual mild pvl and the prosthetic mitral valve gradient was decreased to 8 mmhg.The patient tolerated the procedure well, there were no complications.The patient was clinically and hemodynamically stable and was going to be transitioned to a rehabilitation facility.

Manufacturer Narrative

The device was not returned for evaluation as it remained implanted.Therefore, a no product return engineering evaluation was performed.The device history record (dhr) was reviewed, and the work orders did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to this event.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The complaint for leaflet motion restricted was confirmed from the review of medical record report.A review of dhr, lot history, complaint history review, and manufacturing mitigations did not identify any manufacturing non-conformities that would have contributed to the reported event.Additionally, no ifu/training manual inadequacies were identified.During the manufacturing process, all sapien 3ultra valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.As reported, 'a patient with a 29mm sapien 3 placed in mitral annular calcification (mac) for 9 months was admitted to the hospital with persistent elevated transcatheter mitral valve gradient.A post dilation was performed and the patient was sent to rehab' , and 'per medical records review, the patient was admitted with acute-on-chronic heart failure due to multiple valvular disease.A cardiac catheterization study was done for evaluation and reported severe transcatheter mitral valve stenosis with mitral mean gradient of 14 mmhg.A tte done on the same date reported severe motion restriction (almost immobility) of one of the mitral thv leaflets resulting in severe mitral stenosis.There was also moderate-severe mitral perivalvular leak (pvl)'.It should be noted that implantation of sapien 3 in native mitral valve is not approved for use and considered off-label.Due to limited information and unavailable of imagery, a definitive root cause was unable to be determined at this time.No manufacturing non-conformances were identified during the evaluation.A definitive root cause was unable to be determined.Since no labeling or ifu/training inadequacies were identified, corrective/preventive action nor product risk assessment(pra) is not required.The edwards sapien 3 transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic valve stenosis.Deployment of the sapien 3 valve in a native mitral valve, is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.In this case, there was no allegation or indication a product deficiency contributed to this adverse event.The root cause of the pvl remains indeterminable.But it is likely that patient comorbidities and procedure related factors (native mitral position) may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.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.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12099602
• MDR Text Key: 259391141
• Report Number: 2015691-2021-03870
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)210325
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2021
• Device Model Number: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: 6635918
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention