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

Model Number 9600TFX23A

Device Problems Gradient Increase (1270); Insufficient Information (3190)

Patient Problems Fatigue (1849); Insufficient Information (4580)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by implant patient registry (ipr), 2 years, 5 months, 22 days post implant of a 23mm sapien 3 ultra valve in the aortic position, the valve required intervention and an alternate surgical valve was implanted.The reason for explant is unknown.

Manufacturer Narrative

Supplemental to reflect additional information received during follow-up, update to b4, b5, b7, g3, g6, h2, h6 and h.10.Investigation is ongoing.

Event Description

As reported by implant patient registry (ipr), 2 years, 5 months, 22 days post implant of a 23mm sapien 3 ultra valve in the aortic position, the valve required intervention and a surgical valve was implanted.The reason for explant is stenosis.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from medical records.The product was not returned; therefore, a no product return investigation was completed.As a device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.No imagery was provided.Review of the work orders above did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed using the valve serial numbers from related work order and revealed no other complaints relating to the relevant complaint codes.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The commander delivery system with s3 ifu was reviewed.Valve stenosis is a known potential adverse event.Noted under potential adverse events, 'valve stenosis'.No ifu/training deficiencies were identified.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 the failure mode is not required at this time.The complaint was confirmed based on the medical record.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 3 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, '2 years, 5 months, 22 days post implant of a 23mm sapien 3 valve in the aortic position, the 23 mm sapien 3 valve required intervention and a konect resilia aortic valved conduit was implanted.The reason for explant is stenosis.'.Per ifu, valve stenosis was potential adverse events associated with the use of valve.Per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including pannus, calcification, support structure deformation (out-of-round configuration), trauma (cardia-pulmonary resuscitation, blunt chest trauma), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.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.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 severity it could be an indication for valve replacement or medical intervention.Per medical record, patient had history of hyperlipidemia (hld) and diabetes.These are well-known factors for valve calcification leading to thickened leaflets and resulting in stenosis.In additional noted that patient had history of bacteremia and developed fever one (1) prior to the surgical intervention/ explant.'during explant, vegetations were viewed on the valve and it was fibrotic' per medical record.It indicated the potential endocarditis leading to leaflets damaged resulting in stenosis.As such, available information suggests that patient factors (hyperlipidemia, diabetes, endocarditis) may have contributed to the reported event.Since no device problem was identified affecting distributed product, no pra or capas are required.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.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.

• 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: 16407753
• MDR Text Key: 309866089
• Report Number: 2015691-2023-10961
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)211104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/04/2021
• Device Model Number: 9600TFX23A
• Device Catalogue Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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: 65 YR
• Patient Sex: Female