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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT
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W.L. GORE & ASSOCIATES GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Catalog Number ECH060040J
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
As the devices were not returned, no evaluation of the devices could be performed.
 
Event Description
On an unknown date, in 2018, the patient was implanted with a gore® acuseal vascular graft as an av shunt for hemodialysis on the left forearm.On an unknown date in (b)(6) 2020, a follow-up echo examination showed possibility of the graft delamination.As a treatment, ballooning was performed.The graft remains implanted and the patient is being monitored.The physician reported the inner layer of eptfe appears to have peeled off of the silicon.The physician reportedly suspects cause of the delaminiation may be needle puncture.
 
Manufacturer Narrative
H6: code 4114 - refer to the device evaluation summary below for the results of the engineering evaluation.The identity of the device was not provided; therefore, the device history record could not be examined to identify any potential root causes attributable to the manufacture of the device.The event description could not be confirmed, as no identity or image of the device was provided for evaluation.
 
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Brand Name
GORE ACUSEAL VASCULAR GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key9695599
MDR Text Key187923836
Report Number2017233-2020-00089
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
PMA/PMN Number
K130215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Catalogue NumberECH060040J
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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