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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
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned.Therefore, direct product analysis was not possible.
 
Event Description
In a review of published literature, ¿initial treatment outcome of viabahn in tokyo medical university tokyo medical university hospital¿ masaki kano et al., japan society for vascular surgery journal (0918-6778), volume 27 supplement, page 30-5 (june, 2018), the following findings were noted: during a procedure (unspecified type) in 2017 (exact date unknown), a vessel injury occurred (anatomical location not provided).To achieve homeostasis due to a vessel injury, a gore® viabahn® endoprosthesis with heparin bioactive surface was implanted.The viabahn device was deployed with no issues.However, after deployment the physician noted the vessel injury was not resolved.A surgical procedure was performed to repair the vessel injury.Further information was not available.
 
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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 Key8126034
MDR Text Key129096146
Report Number2017233-2018-00735
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
PMA/PMN Number
P040037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
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) Required Intervention;
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