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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP
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W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP Back to Search Results
Catalog Number VBJR061002A
Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/10/2018
Event Type  malfunction  
Manufacturer Narrative
Results code: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
 
Event Description
The following information was reported to gore: on (b)(6) 2018 a patient was being treated emergently for a hemorrhage.A gore® viabahn® endoprosthesis was loaded over a.018" wire and advanced, but during advancement, the delivery catheter broke.The device was removed entirely and a second device was advanced and deployed successfully.There was no adverse outcome for the patient.
 
Manufacturer Narrative
Results code2: 213: the engineering evaluation stated the following: there was a kink in the distal shaft, upon which the endoprosthesis is mounted, at the transition.The remainder of the device appeared unremarkable.Medwatch #2017233-2018-00730 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch will be retracted.Engineering evaluation conclusions are: based on the device examination performed, no manufacturing anomalies were identified.
 
Event Description
The following information was reported to gore: on (b)(6) 2018 a patient was being treated emergently for a hemorrhage.A gore® viabahn® endoprosthesis was loaded over a.018" wire and advanced, but during advancement, the delivery catheter broke.The device was removed entirely and a second device was advanced and deployed successfully.There was no adverse outcome for the patient.During the course of the investigation it was learned that the delivery catheter did not break apart, but rather it kinked.
 
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Brand Name
GORE VIABAHN® ENDOPROSTHESIS - 3
Type of Device
NIP
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key8123024
MDR Text Key129050331
Report Number2017233-2018-00730
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00733132623969
UDI-Public00733132623969
Combination Product (y/n)N
PMA/PMN Number
P040037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2021
Device Catalogue NumberVBJR061002A
Device Lot Number18269834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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