MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 914ESA

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

Patient Problem Hematoma (1884)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

The time to event [tte in days] for this event was 7.The device identification (di) numbers for edwards esheath introducer set are (b)(4).The instructions for use (ifu) list hemorrhage requiring transfusion or intervention as a potential risk associated with the overall tavr procedure, including potential access complications associated with standard cardiac catheterization.The majority of transfemoral access related bleeding complications are related to diseased ileo-femoral vessels and/or procedural technique during the insertion or removal of the sheath and/or dilators.There are cases where the bleeding is significant and more complex intervention or transfusion is required to treat/prevent a permanent injury from occurring.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the valve can be delivered transfemorally.In this case, specific procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device; however, a transfusion of 2 units or more of blood was reported in the registry.By varc definition, the meet criteria for major vascular complication; therefore, the event is being reported.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.

Event Description

Per the information received from the thv/tvt registry for (b)(6) 2020 data extract for mitral serious injuries for the sapien 3 transcatheter heart valve, a hematoma at access site occurred.No additional information is available for this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10397379
• MDR Text Key: 203154591
• Report Number: 2015691-2020-13045
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 914ESA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR