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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES LLC EDWARDS ESHEATH+ INTRODUCER SET INTRODUCER, CATHETER Back to Search Results
Model Number 914ESP
Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem Vascular Dissection (3160)
Event Date 06/07/2022
Event Type  Death  
Manufacturer Narrative
Investigation is ongoing.
 
Event Description
As reported by the edwards field clinical specialist, this was a case of a 23mm s3 ultra via subclavian approach. While positioning the valve on the balloon, it was noticed that the seam split on the sheath and the valve exited the seam. A dissection occurred outside of the aorta, either in the innominate or subclavian artery. The decision was made to stop and remove everything. However, the system was stuck due to tortuosity. A cutdown was performed. The entire system was removed; however, the vessel had perforated to the point that it was bleeding into the pericardium. The patient could not be taken off bypass and expired. The device was discarded. Sheath insertion was normal. Resistance in device delivery was noted to be normal to more than normal in the torturous section of the artery. Resistance was more than normal as the delivery system was being repositioned to allow for valve alignment.
 
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Brand NameEDWARDS ESHEATH+ INTRODUCER SET
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
renee van dorne
1 edwards way
irvine, CA 92614
9492506385
MDR Report Key14836964
MDR Text Key294829840
Report Number2015691-2022-06418
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number914ESP
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/10/2022
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: 06/27/2022 Patient Sequence Number: 1
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