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

Model Number 9750TFX

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

Patient Problem Heart Block (4444)

Event Date 04/01/2022

Event Type  Death  

Event Description

Thv/tvt registry summary reporting for adverse event submission for quarter 2 2022 data extract for mitral death event for the sapien 3 ultra valve.This report summarizes 1 permanent pacemaker death event for the sapien 3 ultra transcatheter heart valve.The age range for this event is 77 years.The breakdown for gender is as follows: 1 female.

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and summarizes 1 device thrombosis death event for the sapien 3 ultra transcatheter heart valve in the mitral position.The ''time to event'' (tte, in days) for this event was 0.0.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: (b)(4).Per the instructions for use, conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with invasive cardiac interventions, including the use of transcatheter heart valves.Conduction system disturbances during tmvr may be related to several patient factors (pre-operative co-morbid status, the degree mitral annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities) and procedural factors (depth and profile of the implanted prosthesis, sheath, wire and delivery system manipulation).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.However, the conduction disturbance may be related to the potential contributing factors described above.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 at this time.

Manufacturer Narrative

Correction to the exemption number field per fda request on 07/07/2022.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 14892446
• MDR Text Key: 295219769
• Report Number: 2015691-2022-06583
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Exemption Number: 2016006
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 77 YR
• Patient Sex: Female