MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TRANSCATHETER HEART VALVE UNKNOWN; PULMONARY VALVE PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number SAPIEN VALVE UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The type of thv valve is unknown; however, the possible pma numbers associated with an p130009 - edwards sapien xt transcatheter heart valve; p140031- edwards sapien 3 transcatheter heart valve.

Event Description

As reported through a european article, 'implantation of the edwards sapien xt and sapien 3 valves for pulmonary position in enlarged native right ventricular outflow tract'.A single-center study was performed between january 2015 and march 2020, percutaneous pulmonary valve implantation (ppvi) was performed on 129 patients.A retrospective analysis was performed on 84 patients who have undergone successful ppvi implantation using the sapien xt or sapien 3 valves with dilated native right ventricular outflow tract (rvot).In one patient, the valve embolized back to the rvot during valve opening; therefore, could not be further advanced.The patient underwent an urgent surgical pvi.

Manufacturer Narrative

A supplemental mdr is being submitted to provide manufacture report numbers related to this complaint.This report is 1 of 3 being submitted for this complaint.Reference mfg.Report numbers: 2015691-2023-10573 and 2015691-2023-10575.

Manufacturer Narrative

Update to h6 (type of investigation, investigation findings, and investigation conclusions) and h10 to reflect engineering evaluation.The edwards valve was not returned to edwards for evaluation as it was reported through an article.Without the device returned for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.The complaint event occurred between january 2015 and march 2020 using either edwards sapien xt or sapien 3 transcatheter heart valves.The exact procedure date, valve model, and delivery system were unknown for the complaint event.Based on that information the exact ifu/training manual was unable to be determined.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 for thv embolized into ventricle was unable to be confirmed due to unavailability of relevant imagery/medical record.Due to unavailability of valve serial number, dhr review was unable to be performed to determine if a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.It should be noted that the thv implanted in native pulmonic valve for this case, which was off label operation.As reported, 'in one patient, the valve was embolized back to the rvot during valve opening and therefore could not be further advanced, making him undergo urgent surgical pvii'.Valve embolization is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.In this case, available information suggests that procedural factors (off label operation) may have contributed to the complaint event.However, a conclusive root cause was unable to be determine 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 is required at this time.

Manufacturer Narrative

A supplemental mdr is being submitted for the reference of the article.This section h10 (provide narrative/data) has been updated.Bibliography: implantation of the edwards sapien xt and sapien 3 valves for pulmonary position in enlarged native right ventricular outflow tract; a.Guzeltas, ic tanidir, s.Gokalp; anatol journal of cardiol; 2021.

• Brand Name: EDWARDS TRANSCATHETER HEART VALVE UNKNOWN
• 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: 16297240
• MDR Text Key: 308781079
• Report Number: 2015691-2023-10571
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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