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

Model Number 9600TFX29

Device Problem Perivalvular Leak (1457)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 09/30/2019

Event Type  Injury  

Event Description

As reported by our affiliates in (b)(6), through the review of the clinical case: "valve-in-ring transcatheter heart valve for severe tricuspid regurgitation", corresponding author dr.(b)(6) from (b)(6) hospital.Case of a (b)(6) man who was experiencing decompensations of right-sided heart failure 1 year after undergoing valve annuloplasty with a 34-mm carpentier-edwards mc3 band due to severe tricuspid regurgitation with right-sided heart failure.Two months after the surgical repair, severe tricuspid regurgitation had returned and the patient required prolonged hospital admissions.At time of presentation the patient was deemed to be unfit for further surgical intervention and they decided to perform a transcatheter alternative.The valve-in-ring procedure was performed by transfemoral approach with a 29 mm sapien 3 that was slowly deployed across the tricuspid annuloplasty ring.After deployment, right ventriculography and transesophageal echocardiography revealed significant valvular and paravalvular tricuspid regurgitation.The cause of valvular regurgitation was entrapment of 1 leaflet of the sapien 3, which could not be freed by simple wire or catheter manipulation.As a consequence, a second 29-mm sapien 3 thv was implanted in a more ventricular position to overcome the leaflet entrapment.Transesophageal echocardiography confirmed resolution of tricuspid regurgitation, but moderate pvl persisted.No actions were performed during the index procedure.6 weeks post-procedure demonstrated pvl and the patient was readmitted to the hospital due to right-sided heart failure, which mandated pvl closure.For the treatment of pvl, the doctors used a total of 4 amplatzer vascular plugiii.Trans-esophageal echocardiography demonstrated only trivial pvl.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2018-02912 for the report related to the valve in valve procedure.The dates of the event is unknown; however, the article was submitted for publication on september 30, 2019.Therefore, the 'submission for publication date' was used as the occurrence date.The edwards sapien 3 transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic/mitral valve stenosis.Deployment of the sapien 3 valve in a sapien 3 a the tricuspid ring 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 known 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 malfunction contributed to this adverse event.Investigation results are inconclusive, however it could be related to the initial placement of the sapien 3 in the tricuspid ring in the tricuspid position.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 this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.Valve remains implanted.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, 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: 13119648
• MDR Text Key: 287031638
• Report Number: 2015691-2021-07118
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 74 YR
• Patient Sex: Male