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

Model Number 9600TFX

Device Problems Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 12 events of aortic device thrombosis for the sapien 3 valve in the aortic position.The ¿time to event¿ (tte, in days) for this event was 182.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve are: (b)(4).Per the instructions for use (ifu), potential risks associated with the overall procedure include thrombus formation, plaque dislodgment, and embolization that may result in myocardial infarction, stroke, distal peripheral occlusion, and/or death.It is the natural tendency of the body to form clot on foreign objects in the vascular space.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous wiping and flushing of the devices to prevent and/or remove clot.The thv training manuals and ifu instruct the operator to administer heparin and maintain the act at = 250 sec.In this case, specific procedural details were not available to determine potential contributing factors.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.

Event Description

Thv/tvt registry summary reporting for adverse event submission for (b)(6) 2020 data extract for aortic serious injuries for the sapien 3 valve.This report summarizes 12 events of aortic device thrombosis serious injury events for the sapien 3 transcatheter heart valve for (b)(6) 2020.The age range for these events is from 69-89.The breakdown for gender is as follows: 5 females and 7 males.(b)(6) 2020 data extract includes data provided by acc for q4 2019 (october 1 ¿ december 31).

Manufacturer Narrative

Supplemental report to add noe statement in b5 section, d5, f10, h6.

Event Description

This report summarize events of device thrombosis serious injury events for the sapien 3 for may 2020.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10344671
• MDR Text Key: 202357418
• Report Number: 2015691-2020-12834
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 12
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR