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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY
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W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Catalog Number JHJR062502J
Device Problems Inadequacy of Device Shape and/or Size (1583); Device Handling Problem (3265)
Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
 
Event Description
The following was reported to gore: on (b)(6) 2020, the patient presented with peripheral artery disease (pad) in the right common iliac artery and underwent treatment using a non-gore stent (smart).Upon deployment of the smart stent, a dissection of the right common iliac artery was observed at the edge of the stent.The physician decided to place a 6 mm x 2.5 cm gore® viabahn® endoprosthesis (vsx) within the smart stent to treat the dissection.Reportedly, a 6 mm x 25 cm vsx device was accidentally implanted and deployed instead of the 6 mm x 2.5 cm resulting in approximately 20 cm of the vsx device being deployed in the sheath.The physician attempted removing the deployed vsx device using an endovascular technique but was ultimately unsuccessful.The physician decided to remove the vsx device surgically.Further information has been requested.
 
Manufacturer Narrative
H6 clinical code: 4581-appropriate term/code not available: surgical conversion.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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.
 
Event Description
The following was reported to gore: on (b)(6) 2020, the patient presented with peripheral artery disease (pad) in the right common iliac artery and underwent treatment using a non-gore stent (smart).Upon deployment of the smart stent, a dissection of the right common iliac artery was observed at the edge of the stent.The physician decided to place a 6 mm x 2.5 cm gore® viabahn® endoprosthesis (vsx) within the smart stent to treat the dissection.Reportedly, a 6 mm x 25 cm vsx device was accidentally implanted and deployed instead of the 6 mm x 2.5 cm resulting in approximately 20 cm of the vsx device being deployed in the sheath.The physician attempted removing the deployed vsx device using an endovascular technique but was ultimately unsuccessful.The physician decided to remove the vsx device surgically.The patient tolerated the procedure.
 
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Brand Name
GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10856456
MDR Text Key217299574
Report Number2017233-2020-01450
Device Sequence Number1
Product Code NIP
Combination Product (y/n)Y
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 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberJHJR062502J
Was Device Available for Evaluation? No
Date Manufacturer Received10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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