MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Model Number	BXA063902A
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Codes	No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The following was reported to gore: on (b)(6) 2020, the patient presented with occlusion of the bilateral carotid arteries and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and a carotid filter.The physician advanced the carotid filter and the vbx device to the treatment zone and deployed the carotid filter.The vbx device was then deployed successfully.The removal of the carotid filter was then attempted and unsuccessful due to the retrieval wire being positioned between the vbx device and the vessel wall.Another retrieval of the filter was attempted reportedly using a low-profile balloon vertetral quick cross catheter, but was unsuccessful.The physician then decided to grab the filter with a snare but could not proceed any further due to the carotid filter wire remaining between the vbx device and the vessel wall.Contrast was then injected and no blood flow could be observed in the internal carotid artery.The physician then decided to convert to a cut down of the treatment zone to complete the procedure.Further information has been requested.
Additional 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.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.H6 investigation conclusion code updated.
Event or Problem Description
The following was reported to gore: on (b)(6) 2020, the patient presented with occlusion of the bilateral carotid arteries and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and a carotid filter.The physician advanced the carotid filter and the vbx device to the treatment zone and deployed the carotid filter.The vbx device was then deployed successfully.The removal of the carotid filter was then attempted and unsuccessful due to the retrieval wire being positioned between the vbx device and the vessel wall.Another retrieval of the filter was attempted reportedly using a low-profile balloon vertetral quick cross catheter, but was unsuccessful.The physician then decided to grab the filter with a snare but could not proceed any further due to the carotid filter wire remaining between the vbx device and the vessel wall.Contrast was then injected and no blood flow could be observed in the internal carotid artery.The physician then decided to convert to a cut down of the treatment zone to complete the procedure.Further information has been requested but has not been made available at this time.
Event or Problem Description
The following was reported to gore: on (b)(6) 2020, the patient presented with occlusion of the bilateral carotid arteries and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and a carotid filter.The physician advanced the carotid filter and the vbx device to the treatment zone and deployed the carotid filter.The vbx device was then deployed successfully.The removal of the carotid filter was then attempted and unsuccessful due to the retrieval wire being positioned between the vbx device and the vessel wall.Another retrieval of the filter was attempted reportedly using a low-profile balloon vertetral quick cross catheter, but was unsuccessful.The physician then decided to grab the filter with a snare but could not proceed any further due to the carotid filter wire remaining between the vbx device and the vessel wall.Contrast was then injected and no blood flow could be observed in the internal carotid artery.The physician then decided to convert to a cut down of the treatment zone to complete the procedure.Further information has been requested but has not been made available at this time.
Additional 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.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.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10765541
• Report Number: 2017233-2020-01394
• Device Sequence Number: 11578630
• Product Code: PRL
• UDI-Device Identifier: 00733132637195
• UDI-Public: 00733132637195
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: BXA063902A
• Device Catalogue Number: BXA063902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/01/2020; 10/01/2020; 10/01/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 05/03/2021; 05/10/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention