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

Model Number 9600TFX26A

Device Problem Calcified (1077)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Event Description

Edwards received notification from a thv territory manager that a patient underwent a valve in valve procedure.The patient had a surgical valve in the mitral position with 26mm sapien 3 valve that failed after 2 years and 10 months due to calcification leading to stenosis.The patient had multiple chf admissions prior to intervention.During the procedure, the team attempted to cross the septum with valve and pusher.The pusher would not cross the septum.The wire was looped in the left atrium and the operator was unable to advance the valve across the mitral surgical valve.The entire system was removed and the case was aborted.The patient returned 9 days later and a 26mm sapien 3 ultra valve was successfully implanted via the transeptal approach in the preexisting surgical valve.

Manufacturer Narrative

The device was not returned for evaluation.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Edwards' thv valves undergo thermafix tissue processing, which is a heat treatment process used to reduce calcification variability and lower calcification levels in comparison to xenologix process.Clinical results of thv implantation show similar mortality and significantly lower structural valve deterioration (svd) rate compared with surgical aortic valve replacement after 6 years of functioning.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent calcification from occurring in bioprosthetic valves.Furthermore, evaluation of previously reported complaints for valve calcification did not confirm any manufacturing non-conformances and identified that the proper manufacturing mitigations have been implemented.In this case, complaint was unable to be confirmed due to device and imagery unavailability.Based on the limited information provided, the root cause for the valve degeneration approximately 2 years 10 months post valve implant could not be determined, but may be related to the patient's co-morbidities (history of failed kidney transplant) 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.

• 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: 12194125
• MDR Text Key: 262486905
• Report Number: 2015691-2021-04216
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194357
• UDI-Public: (01)00690103194357(17)200402
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Model Number: 9600TFX26A
• 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: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention