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

Model Number 9600TFX20A

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device remains in use.

Event Description

As reported, 2 years 4 months post tavr procedure using a 20mm sapien 3 valve via transfemoral approach, the patient returned to hospital with high gradient >40mmhg.A balloon aortic valvuloplasty was performed to better expand the valve to relieve the gradient that was caused by stenosis.This brought the gradient to 9.5mmhg via catheterization measurement and 11mmhg via transesophageal echocardiography (tee) calculation.The patient had moderate paravalvular leak and was taken to recovery in stable condition.At the time of this report, the team is monitoring the patient to see if further intervention was warranted.

Manufacturer Narrative

The valve was not returned; therefore, a visual inspection, functional testing, or dimensional testing was not performed.Imagery was provided and review revealed the following; pretavr 3mensio revealed the annular area and areaderived diameter measured at 301 mm2 and 19.6 mm, respectively, which is within the acceptable range for a 20mm thv sizing election.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency therefore, no device history record (dhr) review was performed.There was no device returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, therefore a manufacturing mitigation review is not required.The complaint for post implantation increased gradients was unable to be confirmed; therefore, a lot history review and complaint history review was not performed.A risk assessment was performed on the reported event and no evidence of product nonconformances or labeling/ifu inadequacies were identified in the evaluation.The ifu for commander delivery system with s3/s3u/s3ur thv us was reviewed.No ifu/training deficiencies were identified.The complaint for post implantation increased gradients was unable to be confirmed based on provided medical records/imagery.A review of the dhr provided no indication that a manufacturing nonconformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, 20mm sapien 3 ultra returned to hospital with high gradient >40mmhg.The team decided to bav to better expand the valve to relieve the gradient.The physician stated the gradient was caused by stenosis.The bav was done with a 21mm true balloon at nominal prep.The procedure went well and brought the gradient to 9.5mmhg via cath measurement and 11 via tee calculation.Elevated gradients may indicate obstructed flow across the valve.An increase in gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or subvalvular stenosis.Additionally, an increase in gradients can indicate that a leaflet is not functioning optimally due to thrombosis or early valve degeneration.In this case, the event reported that elevated gradients were due to stenosis.Stenosis is generally characterized by narrowing in the effective valve orifice, which can cause the pressure on the front of the valve builds up as blood is forced through the narrow opening, leading to increased pressure gradients across the thv.As such, available information suggests that patient factors (stenosis) may have contributed to the reported event.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions (capa) are required.Since no product nonconformances or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) escalation is not required.

• 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: 16382809
• MDR Text Key: 309637551
• Report Number: 2015691-2023-10840
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194005
• UDI-Public: (01)00690103194005(17)220112
• 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
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: 9600TFX20A
• Device Catalogue Number: 9600TFX20A
• Device Lot Number: 7205182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2020
• Is the Device Single Use?: No
• 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 Sex: Female