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U.S. Department of Health and Human Services

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

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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 Rupture (2208)
Event Date 06/06/2022
Event Type  Death  
Manufacturer Narrative
Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention. 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 the transfemoral passage of the devices. Per the instructions for use (ifu), artery rupture and death are a potential adverse events associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices. In this case, there was no allegation or indication a product malfunction contributed to this adverse event. The root cause of the event remains indeterminable. 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 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.
 
Event Description
Edwards received notification from our affiliate in (b)(6). As reported, the patient underwent a trans-subclavian transcatheter aortic valve replacement (tavr) procedure with a 23mm sapien 3 valve was performed per manual. 14 fr esheath was inserted via left subclavian artery. There was no abnormality during sheath insertion nor resistance during sheath insertion. Post implant, there was no abnormality in the subclavian artery by echography, the patient left the operating room. The patient complained backache and suddenly changed overnight. Percutaneous cardiopulmonary support (pcps) was implemented. Endovascular treatment (evt) was performed emergency. However, the patient did not recover, and then passed away on postoperative day (pod) 3. Per the operator, the causal relation of the event with both the device and the procedure was determined as ''unknown''. The cause of death was reported as left subclavian artery rupture.
 
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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 Key14918895
MDR Text Key295272956
Report Number2015691-2022-06626
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00690103194838
UDI-Public(01)00690103194838(17)231124(10)64120997
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
Type of Report Initial
Report Date 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number914ESJ
Device Catalogue NumberN/A
Device Lot Number64120997
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2021
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: 07/05/2022 Patient Sequence Number: 1
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