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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER INTRODUCER, CATHETER

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EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER INTRODUCER, CATHETER Back to Search Results
Model Number 9610ES14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pseudoaneurysm (2605)
Event Date 01/15/2021
Event Type  Injury  
Manufacturer Narrative
Per the instructions for use (ifu) cardiovascular injury, such as perforation or damage (dissection) of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure. A pseudoaneurysm is a leakage of arterial blood from an artery into the surrounding tissue with a persistent communication between the originating artery and the resultant adjacent cavity. This may occur after arterial puncture for a diagnostic cardiac catheterization or an arteriogram, but is more common after an arterial intervention. Catheter directed interventions more commonly require larger arterial sheaths to be used, and the anticoagulation or antiplatelet agents that are administered can interfere with normal sealing of the puncture site. Some pseudoaneurysms resolve themselves, though others require treatment to prevent hemorrhage, an uncontrolled leak or other complications. Surgery is sometimes required. Access site injuries, are a well recognized complication of the tavr procedure in this elderly population with multiple co-morbidities. 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. The thv training manuals instruct the user to determine with ct if the planned access site is free of calcification, and provides guidance for sheath insertion and removal. Considerations for approach, access and stabilization of the site are also provided in the training. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. The exact cause of the reported event was unable to be determined, but may have been due to patient factors (i. E. Characteristics of access site) and/or procedural factors (i. E. Closure technique) not provided. 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
As reported by an edwards (b)(4) affiliate, on post operative day 3 of a transfemoral tavr procedure with a 26 mm sapien 3 ultra valve, a pseudoaneurysm was detected related to the access site. Medical therapy was used as a treatment, and the event was resolved. Although the aneurysm occurred on the implantation site, there were no difficulties reported in regards to insertion of the devices. Additionally, after removal of the devices, no abnormalities were reported.
 
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Brand NameEDWARDS ESHEATH INTRODUCER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
renee van dorne
1 edwards way
irvine, CA 92614
9492506385
MDR Report Key13840655
MDR Text Key287549244
Report Number2015691-2022-04539
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K200258
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/21/2022
Device Model Number9610ES14
Device Lot Number63310820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/21/2022 Patient Sequence Number: 1
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