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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES EDWARDS ESHEATH PLUS INTRODUCER, CATHETER Back to Search Results
Model Number 914ESPA
Device Problems Material Separation (1562); Failure to Advance (2524)
Patient Problem Rupture (2208)
Event Date 05/26/2022
Event Type  Injury  
Event Description
As reported, during a procedure to implant a 23mm sapien 3 ultra valve in the aortic position via transfemoral approach, the operator encountered resistance during advancement of the valve and delivery system. The vessel was not predilated, the loader was fully inserted into esheath using a standard shallow angle, estimated to be 30 degrees. The 14fr esheath was inserted successfully in the right femoral artery, the valve was inserted via esheath and resistance was met midway through the sheath. Fluoroscopy showed the valve and delivery system exited the seam of the sheath. The valve and delivery system appeared to perforate the seam of the sheath. Attempts were made to pull the valve and delivery system back into the sheath, but the operators were unable to re-sheath the entire system. The system became stuck at the arteriotomy site and the operators saw that a portion of the iliac artery had torn and was on the delivery system. Vascular surgery was called in for a cutdown, surgical repair. The vessel was successfully repaired with multiple stents and a graft.
 
Manufacturer Narrative
Investigation is ongoing. Device expected back.
 
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Brand NameEDWARDS ESHEATH PLUS
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 Key14743483
MDR Text Key295027782
Report Number2015691-2022-06268
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00690103215465
UDI-Public(01)00690103215465(17)240314(11)2203152164274074
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 09/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number914ESPA
Device Lot Number64274074
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/26/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/15/2022
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: 06/20/2022 Patient Sequence Number: 1
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