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

Model Number 9600TFX26

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Valve remains implanted.

Event Description

During a tavr procedure using a 26mm sapien 3 valve via transaortic approach, during inflation of the balloon, the valve jumped into the aorta due to pacing failure.The valve was pulled and implanted in the thoracic aorta and a second valve was implanted in aortic position.The patient has no consequence and is well post-procedure.The operators attested that this incident was not due to edwards device quality issue.

Manufacturer Narrative

Correction to h6; impact code, type of investigation, investigation findings, investigation conclusion.The 26mm sapien 3 valve was not returned for evaluation.Without the return of the device for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.The following instructions for use (ifu) were reviewed: certitude delivery system with sapien 3 and procedural training manual.Based on this review, no ifu/training deficiencies were identified.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 valve embolized into the aorta was unable to be confirmed as no imagery/medical record was provided for evaluation.There was no allegation or indication a device malfunction contributed to this adverse event.A review of ifu/training materials revealed no deficiencies.Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to aortic embolization, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, the release of stored tension during deployment, and movement of the delivery system by the operator.As reported, "during inflation of the balloon, the valve jumped into the aorta due to pacing failure.The valve was pulled and implanted in the thoracic aorta".In this case, the loss of pacing capture caused the valve to jump into the aorta.Per the training manual, loss of pacing capture during valve deployment could lead to "sudden movement during deployment" resulting in the valve embolized into the aorta as reported.Available information suggests that procedural factors (loss of pacing capture) may have contributed to the reported 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 corrective or preventative actions are required.

• 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: 16304451
• MDR Text Key: 308856924
• Report Number: 2015691-2023-10592
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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 Age: 89 YR
• Patient Sex: Male