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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL SHEATH INTRODUCER, CATHETER

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EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number ESHEATH UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Retroperitoneal Hemorrhage (4483)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
This report provides data from thv/tvt registry exemption number e2016006 and summarizes 6 retroperitoneal bleeding serious injury events for the sapien 3 transcatheter heart valve in the aortic position. The 'time to event' (tte, in days) for this event was 0. 5. 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). 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, 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. 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
Thv/tvt registry summary reporting for adverse event submission for q1 2022 data extract for aortic serious injuries for the sapien 3 valve. This report summarizes 6 retroperitoneal bleeding events for the sapien 3. The age range for these events is from 66 to 92. The breakdown for gender is as follows: 4 males and 2 females.
 
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Brand NameEDWARDS TRANSFEMORAL SHEATH
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 Key14136023
MDR Text Key289444356
Report Number2015691-2022-05208
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200258
Exemption Number2016006
Number of Events Reported6
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberESHEATH UNKNOWN
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/23/2022
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: 04/18/2022 Patient Sequence Number: 1
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