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

Model Number UNKNOWN SAPIEN VALVE

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The date of the events is unknown.According to the article all implants were completed between from 2013 to 2019.For this reason, the first day of the range was used as the occurrence date.In this case, the exact valve model number is not available.Therefore, this report will reflect an unknown edwards sapien transcatheter heart valve.The possible pma numbers associated with an sapien xt valve and sapien 3 valve are: p130009 - edwards sapien xt transcatheter heart valve; p140031- edwards sapien 3 transcatheter heart valve.Reference: fuchs, a., urena, m., chong-nguyen, c., kikoine, j., brochet, e., abtan, j., fischer, q., ducrocq, g., vahanian, a., iung, b.And himbert, d., 2020.Valve-in-valve and valve-in-ring transcatheter mitral valve implantation in young women contemplating pregnancy.Circulation: cardiovascular interventions, 13(12), p.E009579.The investigation is in progress, a supplemental report will be submitted.

Event Description

Edwards received notification through the review of the medical article, valve in valve and valve-in-ring transcatheter mitral valve implantation in young women contemplating pregnancy by corresponding author dominique himbert, et al.Per the authors, a single center study was performed in patients with edwards sapien xt and sapien 3 transcatheter heart valves (thv) implanted from 2013 to 2019.The following event was identified as pertaining to an edwards device: one patient needed a second prosthesis implantation due to degeneration.It occurred due to thv deterioration 3.6 years after a viv tmvi in a small bioprosthesis (25 mm magna ease).Additional details were not provided by the authors.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.Device degeneration is a known potential risk associated with the tavr procedure and is listed in the instructions for use (ifu) as a potential adverse event.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.Svd 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.Svd may be mild and not require any intervention or it may be moderate to severe.It can cause the heart to work harder to eject blood from the ventricle.Depending on the severity it could be an indication for valve replacement or medical intervention.Tissue calcification is a very common failure mode.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, complaint was unable to be confirmed due to device unavailability/imagery unavailability.Based on the limited information provided, the root cause for the valve degeneration approximately 3 years 6 months post valve implant could not be determined, but may be related to the patient's co-morbidities and/or progression of the pre-existing valvular disease process.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.This is one of five manufacturer reports being submitted for this article.Please reference related manufacturer report no: 2015691-2021-03656, 2015691-2021-03689, 2015691-2021-03691, and 2015691-2021-03692.

• Brand Name: UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12029668
• MDR Text Key: 257172123
• Report Number: 2015691-2021-03690
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SAPIEN VALVE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention