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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 9610ES16
Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)
Patient Problem Great Vessel Perforation (2152)
Event Date 07/22/2022
Event Type  Death  
Event Description
Edwards received notification from our affiliate in switzerland. As reported, this was a case of an implant of a 29mm sapien 3 valve, in the aortic position by transfemoral approach. During the procedure, the vessel was not pre-dilated. While advancing the commander delivery system with the crimped valve through the esheath, high resistance was found and push force was needed at the expandable part of the esheath there was a sudden loss of resistance and the commander with valve slid out the esheath liner causing a perforation/rupture of the severely calcified infrarenal aorta. After placing the blocking balloon in the aorta, the patient was hemodynamically stable, and an emergency endovascular aneurysm repair (evar) was performed. The commander with the crimped valve and the esheath were removed as a single unit. Upon inspection, it was noticed that there were some valve struts bent which probably occurred when retracting the delivery system with the valve into the esheath. A second sapien 3 kit was used for successfully implanting the sapien 3 valve. Unfortunately, the patient passed away one week later from cerebral ischemia. As per medical opinion, the root cause of the event might be related to the high tortuosity and calcification of the infrarenal artery, in combination with the esheath.
 
Manufacturer Narrative
The investigation is ongoing. A supplemental report will be completed upon completion.
 
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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 Key15236768
MDR Text Key298003200
Report Number2015691-2022-07346
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 10/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9610ES16
Device Catalogue NumberN/A
Device Lot Number64182182
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2022
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: 08/16/2022 Patient Sequence Number: 1
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