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

Model Number 9600TFX23A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

The instructions for use (ifu) lists cardiovascular injury that may require intervention (including perforation or dissection of vessels, ventricle, myocardium or valvular structures, annular tear or rupture) as a potential risk associated with the overall tvr procedure.Cardiac aneurysms have been reported as a rare complication following surgical or transcatheter valve replacement.This type of defect in the cardiac tissues or aortic wall can result from trauma during percutaneous valve implantation or additional in-valve balloon dilation on a heavily calcified native valve.Percutaneous/surgical intervention may be required.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The exact cause of the aneurysm post procedure is unknown, however many be due to patient/procedural factors.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.

Event Description

As reported, approximately 3 days post transcatheter pulmonic valve replacement (tpvr) with a 23mm sapien 3 valve, an aneurysm was observed, and a covered stent was implanted to repair the pulmonary artery aneurysm.Next, a 2nd valve was placed within the covered stent.The patient is stable post procedure.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect (common device name, product code, pma number, or other missed or incorrect information).A correction to field g4 is being submitted in this supplemental report.

• 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
• 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: 11440951
• MDR Text Key: 242793253
• Report Number: 2015691-2021-01755
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194005
• UDI-Public: (01)00690103194005(17)210921
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: 9600TFX23A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• 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 Sex: Male