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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY
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W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Device Problems Expulsion (2933); Migration (4003)
Patient Problems Occlusion (1984); Complaint, Ill-Defined (2331); No Information (3190)
Event Date 01/06/2020
Event Type  Injury  
Manufacturer Narrative
Instructions for use for gore® viabahn® endoprosthesis (ifu): intended use / indications: the gore® viabahn® endoprosthesis is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries.
 
Event Description
The following article was reviewed: in the article, o'connor kp, bohnstedt bn.Viabahn stent extrusion into the airway in association with nasopharyngeal squamous cell carcinoma.Interdisciplinary neurosurgery 2019;18.Article 100464.Viabahn was placed in the carotid artery of a patient with nasopharygeal squamous cell carcinoma to treat "carotid blowout syndrome".Six months later, the stent was extruded into the airway and the patient coughed up the stent.The authors conclude: "our patient had stent extrusion into the airway approximately six months after placement.The patient reported to the clinic one week after extrusion without bleeding or symptomatology.Ct neck angiography demonstrated that the vessel thrombosed from the common carotid at the level just off the aortic arch to the internal carotid at the level of the cavernous sinus.The patient also had sufficient collateral flow from the contralateral side which allowed avoidance of neurological symptoms secondary to brain ischemia.We believe this to be a unique situation following vessel protection.The patient experienced vessel occlusion with stent extrusion.".
 
Event Description
The following article was reviewed: in the article, o'connor kp, bohnstedt bn.Viabahn stent extrusion into the airway in association with nasopharyngeal squamous cell carcinoma.Interdisciplinary neurosurgery 2019;18.Article 100464.Viabahn was placed in the carotid artery of a patient with nasopharygeal squamous cell carcinoma to treat "carotid blowout syndrome".Six months later, the stent was extruded into the airway and the patient coughed up the stent.The authors conclude: "our patient had stent extrusion into the airway approximately six months after placement.The patient reported to the clinic one week after extrusion without bleeding or symptomatology.Ct neck angiography demonstrated that the vessel thrombosed from the common carotid at the level just off the aortic arch to the internal carotid at the level of the cavernous sinus.The patient also had sufficient collateral flow from the contralateral side which allowed avoidance of neurological symptoms secondary to brain ischemia.We believe this to be a unique situation following vessel protection.The patient experienced vessel occlusion with stent extrusion.".
 
Manufacturer Narrative
Instructions for use for gore® viabahn® endoprosthesis (ifu): intended use / indications: the gore® viabahn® endoprosthesis is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
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Brand Name
GORE VIABAHN ENDOPROSTHESIS
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10451995
MDR Text Key206585312
Report Number2017233-2020-01165
Device Sequence Number1
Product Code NIP
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,litera
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age48 DA
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