• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET INTRODUCER, CATHETER Back to Search Results
Model Number 914ESJ
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pseudoaneurysm (2605)
Event Date 06/07/2022
Event Type  Injury  
Manufacturer Narrative
According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement 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. The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications. The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed. It also notes that calcification may reduce lumen diameter and limit or prevent transfemoral passage of the devices. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. With the limited information provided, the cause of the reported pseudoaneurysm could not be determined. Although the exact cause of the pseudoaneurysm cannot be confirmed, procedural factors (hematoma at the access site), in addition to patient vascular factors (not provided) may have contributed to the post procedure event. 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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review. No corrective or preventative actions are required. Device discarded.
 
Event Description
As reported through the japanese tavi registry, a 26mm sapien 3 valve was deployed in the aortic annulus via a transaxillary or trans-subclavian. After tavr procedure on the way back from the operating room, the patient began to swell in the lateral left axilla and hypotension was observed. Emergency endovascular treatment (evt) was performed to stop the bleeding of the pseudoaneurysm caused by a hematoma at the puncture site. The outcome was determined as recovered.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEDWARDS ESHEATH INTRODUCER SET
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 Key14957934
MDR Text Key295504754
Report Number2015691-2022-06677
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K200258
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number914ESJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/15/2022
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 Treatment Data
Date Received: 07/08/2022 Patient Sequence Number: 1
-
-