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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 9610ES14
Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Patient Problem Vascular Dissection (3160)
Event Date 08/11/2022
Event Type  Injury  
Event Description
As reported, it was a case of an implant of a 20mm valve, in aortic position by transfemoral approach. During the delivery system insertion, a resistance was noted at the end of the sheath and the valve was stuck. After multiple attempts, the valve successfully passed through the esheath. The valve was deployed smoothly. Upon removal of the delivery system and esheath, no flow in the left femoral (access site) was noted and the distal tip of the esheath was torn. Left femoral artery dissection occurred and was treated by a cover stent. Patient is hemodynamically stable.
 
Manufacturer Narrative
The investigation is ongoing. The device has not been returned.
 
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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 Key15330926
MDR Text Key299042264
Report Number2015691-2022-07638
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9610ES14
Device Lot Number64162396
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/05/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/21/2022
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: 08/31/2022 Patient Sequence Number: 1
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