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

Model Number 9600TFX29

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Event Description

As reported, it was a case of a 29mm sapien 3 transcatheter heart valve, in aortic position by left subclavian approach.During procedure, alignment difficulties were experienced.Once the valve was aligned, it was noted that the balloon was distally advanced and was re-aligned twice.During valve deployment, the balloon started filling distally.The valve was partially deployed distally when the valve jumped up from the annulus towards aorta.The delivery system was unable to be advance in order to reposition the valve and finalize the deployment.Therefore, it was decided to retrieve the valve to the left subclavian.The valve was removed surgically and a surgical valve was implanted.Surgery was successfully completed.There was no damage and no balloon leak during inflation were noted.

Manufacturer Narrative

The implant site characteristic is unknown.The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction information.The following sections of this report have been updated: corrected information to h.6 impact code.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 investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device 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 no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was unable to be confirmed as no imagery/medical report was provided for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.As reported, ''during procedure, alignment difficulties were experienced.Once the valve was aligned, it was positioned for deployment and the pusher was retrieved.Then, it was noticed that the balloon was distally advanced, it was needed re-align twice.When the deployment of the valve started, the balloon started filling distally.The valve, mounted on the balloon and partially deployed distally, jumped up from the annulus towards aorta.''.Per the instructions for use (ifu), valve embolization is a known potential complication associated with the transcatheter aortic valve replacement (tavr) procedure.In this case, the distal of inflation balloon was first inflated leading to valve embolized into aorta, which was indicating the valve was not align within the valve alignment markers or too proximal of inflation balloon prior to valve deployment.Per training manual, ''the thv is exactly between the valve alignment markers with no gap or overlap''.As such available, information suggests that procedural factors (improper valve alignment prior deployment) may have contributed to the complaint event.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: AORTIC 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: 16427665
• MDR Text Key: 310065560
• Report Number: 2015691-2023-11006
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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