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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL Back to Search Results
Catalog Number BXA075902A
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2020
Event Type  malfunction  
Manufacturer Narrative
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 for a thoracic branch fenestration in the renal artery and underwent treatment using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The vbx device was inserted into the right groin with the aid of a 14fr dry seal sheath and advanced on a.026 rosen wire to the left renal artery using a nagare(tm) steerable sheath.The physician had difficulty advancing the nagare(tm) steerable sheath further up in the aorta for deployment of the vbx device, the physician then decided to remove the vbx device.Upon removing the endoprosthesis, the stent dislodged from the delivery system within the nagare(tm) steerable sheath.Upon noticing this, the doctor pushed the vbx device out to the aortic aneurysm and deployed a cook endovascular device, pinning the fully constrained vbx device between the vessel wall and the cook endovascular device.Another vbx device was successfully implanted.The patient tolerated the procedure.
 
Manufacturer Narrative
Engineering evaluation: the device remains implanted and was not returned.The following evaluation is based on information obtained from the event description and communication summary.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.Crush force is controlled through machine maintenance and calibration.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.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.Section d4 has been updated to reflect the correct device information.Section h4/h5 has been updated to reflect the correct manufacturing date.
 
Event Description
The following was reported to gore: on (b)(6) 2020, the patient presented for a thoracic branch fenestration in the renal artery and underwent treatment using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The vbx device was inserted into the right groin with the aid of a 14fr dry seal sheath and advanced on a.026 rosen wire to the left renal artery using a nagare steerable sheath.The physician had difficulty advancing the nagare steerable sheath further up in the aorta for deployment of the vbx device and decided to remove the vbx device.Upon removing the endoprosthesis, the stent dislodged from the delivery system within the nagare steerable sheath.Upon noticing this, the doctor pushed the vbx device out to the aortic aneurysm and deployed a cook endovascular device, pinning the fully constrained vbx device between the vessel wall and the cook endovascular device.Another vbx device was successfully implanted.The patient tolerated the procedure.
 
Event Description
The following was reported to gore: on (b)(6) 2020, the patient presented for a thoracic branch fenestration in the renal artery and underwent treatment using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The vbx device was inserted into the right groin with the aid of a 14fr dry seal sheath and advanced on a.026 rosen wire to the left renal artery using a nagare steerable sheath.The physician had difficulty advancing the nagare steerable sheath further up in the aorta for deployment of the vbx device and decided to remove the vbx device.Upon removing the endoprosthesis, the stent dislodged from the delivery system within the nagare steerable sheath.Upon noticing this, the doctor pushed the vbx device out to the aortic aneurysm and deployed a cook endovascular device, pinning the fully constrained vbx device between the vessel wall and the cook endovascular device.Another vbx device was successfully implanted.The patient tolerated the procedure.
 
Manufacturer Narrative
Engineering evaluation: the device remains implanted and was not returned.The following evaluation is based on information obtained from the event description and communication summary.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.Crush force is controlled through machine maintenance and calibration.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.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.
 
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Brand Name
GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
Type of Device
ILIAC COVERED STENT, ARTERIAL
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10771718
MDR Text Key214551770
Report Number2017233-2020-01399
Device Sequence Number1
Product Code PRL
Combination Product (y/n)Y
PMA/PMN Number
P160021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/06/2023
Device Catalogue NumberBXA075902A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/05/2020
Initial Date FDA Received11/02/2020
Supplement Dates Manufacturer Received10/05/2020
10/05/2020
Supplement Dates FDA Received02/24/2021
04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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