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

Model Number 9600TFX23A

Device Problem Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2022

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), approximately 3 years and 4 months post-implant of a 23 mm sapien 3 valve in the pulmonic valve via transfemoral approach, the valve failed due to regurgitation and paravalvular leak (pvl).A valve in valve was successfully implanted.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions.Added new information to h.6 type of investigation and investigation findings.The sapien 3 valve was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was confirmed based on provided medical records.A review of dhr, lot history and complaint history 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, ''approximately 3 years and 4 months post-implant of a 23 mm sapien 3 valve in the pulmonic valve via transfemoral approach, the valve failed due to paravalvular leak (pvl) regurgitation.'' per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valve and the transcatheter valve replacement procedure.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.Per reviewed medical records, patient had a complex history of congenital heart disease and the presence of pulmonic homograft at the implantation site (human tissue graft from a donated heart designed to replace native valve).It is possible that these patient factors contributed toward changing the cardiac structure over time, leading to paravalvular leak (pvl).However, due to insufficient information, a definitive root cause was unable to be determined 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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY 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: 14117987
• MDR Text Key: 289329677
• Report Number: 2015691-2022-05102
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)190807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2019
• 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: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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: 28 YR
• Patient Sex: Male