MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS ESHEATH INTRODUCER SET UNKNOWN; INTRODUCER, CATHETER

Model Number ESHEATH UNKNOWN

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/01/2022

Event Type  Death  

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and summarizes 3 bleeding - access site 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 2.67.Due to the limited information and the data received, edwards cannot confirm which esheath was used in this case, the esheath+ or esheath introducer set.The device identification (di) numbers for edwards expandable introducer sheath + set are (b)(4) and (b)(4).The device identification (di) numbers for edwards esheath introducer set are (b)(4), (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, 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.A transfusion 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.Summary reporting.

Event Description

Thv/tvt registry summary reporting for adverse event submission for quarter 2 2022 data extract for aortic death events for the sapien 3 ultra valve.This report summarizes 3 bleeding - access site death events for the sapien 3 ultra transcatheter heart valve.The age range for these events is 72-91 years.The breakdown for gender is as follows: 2 females and 1 male.

Manufacturer Narrative

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

• Brand Name: EDWARDS ESHEATH INTRODUCER SET UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• 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: 15048907
• MDR Text Key: 296121306
• Report Number: 2015691-2022-06849
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Exemption Number: 2016006
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• 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: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESHEATH UNKNOWN
• 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: 83 YR