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

Model Number 9600TFX26

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

Patient Problems Cardiac Tamponade (2226); Foreign Body Embolism (4439)

Event Date 12/19/2022

Event Type  Death  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our edwards affiliate in france, a 26mm sapien 3 valve was deployed in the aortic position.During valve deployment, a premature ventricular contraction occurred during the sustained rapid pacing, resulting in the embolization of the valve.Due to the large size of the patient aorta, the valve was retracted to the iliac part of the abdominal aorta and deployed.Post valve deployment in the abdominal aorta, the patient's blood pressure dropped, and a pericardial effusion was confirmed by echo.Two (2) liters of blood was drained.The patient was transferred to intensive care (icu) with the drain and a cell-saver.No surgery was performed.The patient expired in the icu.The cause of the cardiac tamponade was not determined.It was speculated that manipulation of the embolized valve may have desiccated the aorta.

Manufacturer Narrative

Update to h6 (type of investigation, investigation findings, and investigation conclusions) and h10 to reflect engineering evaluation.The 26mm sapien 3 valve was not returned to edwards for evaluation as it remains implanted in the patient.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.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.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential adverse events associated with the overall thv procedure and may require intervention.There are several potential etiologies for ventricular perforation during a thv procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.Per the instructions for use (ifu), aortic dissection is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.The complaint for thv embolized into aorta post implant 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 the valve deployment, under sustained rapid pacing, pacing default caused a premature ventricular contraction causing embolization of the valve.The valve had to be retracted down to the iliac part of the abdominal aorta due to the big size of patient's aorta and to correctly deploy and stabilize the valve'.Per the instructions for use (ifu), valve embolization is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was a pvc (premature ventricular contractions) due to a loss of pacing.The sudden blood ejection resulted from premature contractions may have caused the valve to move toward aortic direction during deployment leading to embolization.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 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.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate procedural factors (trying to pull the embolized valve down to the iliac, loss of pacing) could have caused or contributed to this 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 pra is required at this time.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• 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: 16137453
• MDR Text Key: 307083275
• Report Number: 2015691-2023-10073
• 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
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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; Death
• Patient Age: 94 YR
• Patient Sex: Male