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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES LLC EDWARDS TRANSFEMORAL ESHEATH UNKNOWN INTRODUCER, CATHETER Back to Search Results
Model Number ESHEATH UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Vascular Problem (4441)
Event Date 04/01/2022
Event Type  Death  
Manufacturer Narrative
This report provides data from thv/tvt registry exemption number e2016006 and 25 major vascular complication 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 15. 76. 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). 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. According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, vascular complications are a well-recognized complication of the transfemoral tavr procedure in this elderly population with multiple co-morbidities. Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications. Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur. 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. 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 thv can be delivered transfemorally. Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters. The operators are trained to measure minimum vessel diameter taking calcium into account. The physician training manual also lists the minimum recommended vessel size for each size device. Despite the best screening tools, a small percentage of patients will have femoral/iliac vessels that are not amenable to the trans-femoral approach or where increased resistance is encountered during insertion of devices. In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size. In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event. 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 quarter 2 2022 data extract for aortic death events for the sapien 3 ultra valve. This report summarizes 25 major vascular complication death events for the sapien 3 ultra transcatheter heart valve. The age range for these events is 57-92 years. The breakdown for gender is as follows: 11 females and 14 males.
 
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Brand NameEDWARDS TRANSFEMORAL ESHEATH UNKNOWN
Type of DeviceINTRODUCER, 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 Key15048896
MDR Text Key296120826
Report Number2015691-2022-06846
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200258
Exemption Number2016006
Number of Events Reported25
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Health Professional,User Facility
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 Received07/18/2022
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 Received07/07/2022
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 Treatment Data
Date Received: 07/18/2022 Patient Sequence Number: 1
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