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

Model Number 9600TFX26A

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2023

Event Type  Injury  

Event Description

As reported by the field clinical specialist, during a transfemoral tavr procedure with a 26mm sapien 3 valve in the pulmonic position, the valve deployed too distal in the main pulmonary artery (mpa), causing reduction of flow into the right pulmonary artery (rpa).Per field clinical specialist, the presumed root cause of the malpositioned valve was due to the physician did not hold the device properly.The treatment for the "valve deployed too distal in the mpa" was to bend in a portion of the s3 to allow for both systolic and diastolic flow.The team bent the frame of the s3 inward with a balloon to provide more flow to the rpa.The patient's status post procedure resulted as intended.There was no alleged ew device malfunction/deficiency that caused or contributed to the event.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: clinical code, device code, type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned, an imaging evaluation was unable to be performed as no imagery was provided.As no device was returned, engineering was unable to perform visual inspection, functional testing, or dimensional testing.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 this adverse event is not required at this time.The complaint was unable to be confirmed due to unavailable of medical record and relevant imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.Per instructions for use (ifu), valve malposition requiring intervention is a known potential adverse event associated with the transcatheter heart valve (thv) replacement procedure.As reported, "26mm sapien 3 valve in the pulmonic position, the valve deployed too distal in the main pulmonary artery (mpa), causing reduction of flow into the right pulmonary artery (rpa)".In this case, the root cause was presumed to me "due to the physician did not hold the device properly".As such, available information suggests that procedural factors (valve position and deployment technique) may have contributed to the complaint event.The ifu and training manuals have been reviewed and no labeling/ifu deficiencies were identified, 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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No device problem or manufacturing non-conformance that would have contributed to the complaint event was identified during the evaluation.Therefore, no corrective or preventative actions nor product risk assessment escalation is required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, PULMONIC VALVE, 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: 16224586
• MDR Text Key: 307910849
• Report Number: 2015691-2023-10309
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194357
• UDI-Public: (01)00690103194357(17)251023
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX26A
• Device Catalogue Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: Female