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

Model Number 9600TFX26A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).A device history record (dhr) review performed did not reveal any issues that may have contributed to the complaint event.Investigation is ongoing.

Event Description

As reported, approximately six months post valve in ring (26mm sapien 3 in 32mm mitral ring) tvr procedure in the mitral position, the 26mm sapien 3 valve was explanted and replaced with a surgical valve due to mitral stenosis.The patient left the or in stable condition.

Manufacturer Narrative

Correction/additional information: section b3.Additional information: section b7, h6 and h10.Section h10.Additional information provided by the hospital medical records indicated that five months post implant of a 26mm sapien 3 valve in the mitral position, the patient was admitted with severe mitral stenosis.The valve was stated to be "not functioning well".Two days later the 26mm sapien 3 valve was explanted and replaced with a surgical valve.Post op the patient was in cardiogenic shock, renal failure, and hypoxic respiratory failure.The patient later recovered and was transferred to the stepdown unit for further monitoring.Post procedure (date unknown) the patient's surgical avr was explanted and a 32mm cardiomedics mitral ring was deployed followed by the placement of a 26mm sapien 3 valve.Post op echo revealed a 26mm sapien 3 valve in the mitral position, (previous annuloplasty ring) well placed with no mitral regurgitation and a mean mitral gradient of 6mmhg.The valve was not returned to edwards lifesciences for evaluation.Information regarding the disposition of the valve was not provided.Stenosis of an implanted valve may be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.There are cases of svd that result in a combination of regurgitation and stenosis.It may be mild and not require any intervention or it may be moderate to severe.In these cases, it causes the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.It is possible patient factors such as metabolic issues contributed to the valve stenosis.A very common failure mode is tissue calcification.The mechanisms for bioprosthetic heart valve tissue calcification are not fully understood.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.In this case, the cause of the stenosis is unknown, however may be due to the patients pre-existing valvular disease process, co-morbidities (ckd), and/or the mechanisms described above.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9891950
• MDR Text Key: 190124971
• Report Number: 2015691-2020-11216
• Device Sequence Number: 1
• Product Code: NPU
• 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,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2021
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 03/27/2020; 04/21/2020
• Supplement Dates FDA Received: 04/20/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR