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

Model Number 9600TFX26A

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist, approximately 3 months post deployment of a 29mm sapien 3 valve in a 25mm surgical valve in the pulmonic position, a 26mm sapien 3 valve was implanted valve in valve due to pulmonic insufficiency (pi).The pi was resolved and patient left the room in stable condition.

Manufacturer Narrative

The edwards sapien 3 transcatheter valve was not returned for evaluation.The device is not accessible for testing, as the valve is implanted in the patient.A review of the device history record (dhr) and work orders did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review of the work order was performed and revealed no other complaints relating to the complaint codes.Since 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.No imagery was provided for review.The instructions for use (ifu) for procedural training and pulmonic procedural training manuals - commander delivery system with s3, us were reviewed for instructions relating to the complaint.Per warnings/precautions.Correct sizing of the valve into the non-compliant rvot conduit or failing bioprosthesis (landing zone) is essential to minimize risks.Too small of a valve may result in paravalvular leak, migration, or valve embolization, whereas too large of a valve may result in residual gradient (patient-prosthesis mismatch) or rvot rupture.Accelerated deterioration of the transcatheter heart valve (thv) may occur in patients with an altered calcium metabolism.Based on the review of the ifu and procedural training manual, no deficiencies were identified.Since there was no product non-conformance identified, a product risk assessment (pra) escalation is not required.There were no manufacturing non-conformances or ifu/training deficiencies identified, corrective/preventative action (capa) is not required.The complaint for "post-implantation - central regurgitation" was unable to be confirmed.Due to the unavailability of the device and/or relevant imagery, engineering was unable to perform any visual, functional, or dimensional analysis.A review of lot history revealed no indication that a manufacturing non-conformance contributed to the complaint.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.In this case, "the initial 29mm was implanted in a 25mm epic surgical valve." there are several patient and/or procedural factors that alone or in combination that could impact leaflet motion, including thickening of the leaflet, pannus growth, thrombosis, calcification, malposition of the valve, over/under expansion of the valve, incorrect sizing, etc.Due to unavailability of returned device and imagery, a definitive root cause is unable to be determined at this time.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.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 HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12344951
• MDR Text Key: 267358200
• Report Number: 2015691-2021-04754
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)230104
• Combination Product (y/n): N
• PMA/PMN Number: P200015
• 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: 10/14/2021

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: 01/04/2023
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR