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

Model Number 9750TFX20

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); Cardiogenic Shock (2262)

Event Date 02/07/2024

Event Type  Death  

Event Description

As reported by our edwards lifesciences affiliate in germany, during the transfemoral transcatheter aortic valve replacement (tavr) procedure with a 20 mm sapien 3 ultra valve, the valve was implanted in the 95/5 (aortic/ventricular) position.The outcome was not ideal as the patient was still observed with regurgitation.It was unable to be confirmed from the angiogram and transesophageal echocardiography (tee) if the regurgitation was aortic insufficiency or a paravalvular leak (pvl).The valve was post-dilated with an 18f non-edwards balloon with 1 less milliliter (ml), but the regurgitation remained.Approximately 50 minutes later, the patient went into cardiogenic shock and needed to be resuscitated.Subsequently, the patient passed away due to an annular rupture.

Manufacturer Narrative

Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures, and hematoma are known potential adverse events associated with the overall transcatheter heart valve (thv) procedure and may require intervention.According to the thv training manuals, risk factors for aortic dissection, hematoma, or annular rupture during the thv procedure include significant thv over sizing, severely obliterated sinuses of valsalva, porcelain aorta and/or presence of bulky calcification, and narrow calcified stj.In addition, advanced age, female gender, small body weight, and steroid dependency can also be contributing factors.The sapien valve relies on native valve calcium to securely anchor to the annulus.Despite this beneficial aspect of calcium, bulky calcium can increase the risk of calcific nodule displacement into the vasculature, which can lead to vascular injury.At times, the extent and distribution of calcium can impair ease of delivery of the valve, correct positioning of the valve, deployment of the valve, and procedural success.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest patient factors (bulky calcium deposit in the left ventricular outflow tract) caused or contributed to this event.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 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.The investigation is ongoing.H3 other text : device remains implanted.

Manufacturer Narrative

Corrections have been made as follows: adverse event/ product problem change from both to adverse event recall (z) number from res 88058 to z-1974-2021.

• Brand Name: EDWARDS SAPIEN 3 ULTRA 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: 18808098
• MDR Text Key: 336567849
• Report Number: 2015691-2024-01452
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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 Sex: Female