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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 916ESPA
Device Problem Difficult to Remove (1528)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Vascular Problem (4441)
Event Date 07/19/2022
Event Type  Death  
Event Description
As reported by an edwards field clinical specialist, prior to the transfemoral tavr, it was noted that the patient access vessels were tortuous and calcified. During the procedure, difficulties were encountered during the advancement of a 29mm sapien 3 valve and delivery system through the esheath+, resulting in the delivery system buckling. The valve and delivery system exited through the side of the sheath and became struck in the right external iliac artery (reia). Attempts were made to get the valve back into the sheath, which resulted in valve movement on the balloon. While the valve was still on the balloon, the delivery system hypotube was cut and the delivery system and sheath were removed. The valve remained lodged in the reia. Unsuccessful attempts were made to snare the nosecone and valve. During the attempts, the right common femoral artery (rcfa) evulsed, causing major bleeding. The patient received 7+ units of packed red blood cells (prbc). A vascular cutdown was attempted but was unsuccessful. The patient expired after several hours of attempting to correct the complications.
 
Manufacturer Narrative
Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803. 56 when additional information becomes available. This is one of two manufacturer reports being submitted for this case.
 
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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 Key15160921
MDR Text Key297206778
Report Number2015691-2022-07140
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
Report Date 09/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number916ESPA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/22/2022
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: 08/03/2022 Patient Sequence Number: 1
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