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

Model Number 9750TFX

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2022

Event Type  Death  

Event Description

Thv/tvt registry summary reporting for adverse event submission for quarter 4 2022 data extract for aortic death events for the sapien 3 ultra valve.This report summarizes 6 percutaneous coronary intervention death events for the sapien 3 ultra transcatheter heart valve.The age range for these events is 70-90 years.The breakdown for gender is as follows: 9 females.

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and summarizes 6 percutaneous coronary intervention death events for the sapien 3 ultra transcatheter heart valve in the aortic position.The "time to event" (tte, in days) for this event was 0.33.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: 00690103201314, 00690103201321, 00690103201338.Per the instructions for use (ifu), coronary flow obstruction is a potential adverse event associated with the tavr procedure.The ifu cautions that the safety and effectiveness have not been established in patients with bulky calcified aortic valve leaflets in close proximity to the coronary ostia.In addition, it warns that caution should be exercised in implanting a bioprosthesis in patients with clinically significant coronary artery disease.Coronary obstruction can result in myocardial ischemia or infarction due to obstruction of the coronary blood flow and may require intervention (e.G., pci).There are multiple patient factors that could put the patient at risk for coronary flow obstruction during the tavr procedure, including significant underlying coronary artery disease and bulky calcification of the native leaflets and root.Displacement of calcium deposits with embolization of debris into one of the arteries, or aortic dissection with continuity of the rupture into the intima of one of the coronary ostia, can result in this complication.The edwards thv manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device.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 on a monthly basis, 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: EDWARDS SAPIEN 3 ULTRA TRANSCATHER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16030701
• MDR Text Key: 305970116
• Report Number: 2015691-2022-09886
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Exemption Number: E2016006
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Age: 80 YR