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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ESHEATH PLUS INTRODUCER SHEATH INTRODUCER, CATHETER

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EDWARDS LIFESCIENCES ESHEATH PLUS INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number 914ESPA
Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)
Patient Problem Perforation of Vessels (2135)
Event Date 06/28/2022
Event Type  Death  
Manufacturer Narrative
Investigation is ongoing.
 
Event Description
Per the field clinical specialist (fcs), during a tavr procedure using a 26mm sapien 3 ultra valve via a transfemoral approach, there was difficulty inserting valve and delivery system. The vessel was predilated with a 16fr dilator, the loader was fully inserted into sheath. The delivery system was in the expandable portion of the sheath when the resistance was met. When the operators attempted to advance the delivery system (ds) again, it visibly buckled likely due to calcium in vessel. The sheath, valve & ds were removed as a unit and upon removal blood pressure dropped. Upon examination of the system, the valve was seen outside the sheath seam and iliac tissue was visualized on the sheath. The patient was intubated, vascular called and balloons inserted to facilitate endovascular repair of the entire left iliac system. Once control of the iliac system was gained, the physicians proceeded with a valve implant via a left subclavian approach due to a concern for not being able to extubate without placing a valve. The valve delivery was uncomplicated through left subclavian. It was noted that >14 units of blood and >10units fresh frozen plasma. Patient passed away 2 days post procedure.
 
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Brand NameESHEATH PLUS INTRODUCER 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 Key15080110
MDR Text Key296367551
Report Number2015691-2022-06929
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 Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number914ESPA
Device Lot Number64266566
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2022
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: 07/21/2022 Patient Sequence Number: 1
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