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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 914ESPA
Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 07/25/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing. The device is not returning.
 
Event Description
As reported by a field clinical specialist (fcs), during the procedure of a 23 mm sapien 3 ultra valve in the aortic valve in a surgical valve via transfemoral approach. The first esheath was not able to track up the aorta and had noticeably separated from the introducer at the tip on fluoroscopy. A new sheath was prepared and the guide wire was replaced, the sheath was tracked without issue. During deployment, the team was unable to cross the surgical valve. After multiple tries and techniques the patient went into ventricular fibrillation (v-fib) arrest. Cpr, multiple shocks and a left main stent deployment were performed. The patient eventually regained a rhythm and blood pressure. It was decided to abort the procedure at this time. The patient is stable and will be re-evaluated for a open heart surgery. Per the fcs response, during fluoroscopy, it was noted that the first esheath's tip was getting caught on the calcium and distal tip torn was noted. There was no allegation that the ew device cause or contributed to the inability to cross the surgical valve. Left main stent was deployed because no flow was noted down the left main. The stent was already parked in the lad for protection and was planned to be deployed after we implanted the valve and "snorkled" into the aorta.
 
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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 Key15250084
MDR Text Key302059342
Report Number2015691-2022-07391
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00690103215465
UDI-Public(01)00690103215465(17)240404(11)2204052164307748
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 10/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number914ESPA
Device Catalogue Number914ESPA
Device Lot Number64307748
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/03/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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