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

Catalog Number BXA075901J

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Occlusion (1984); Claudication (2550); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/29/2020

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 information was reported to gore: on (b)(6) 2020, the patient presented with total occlusion in the left common iliac artery and underwent treatment utilizing four gore® viabahn® vbx balloon expandable endoprosthesis (vbx).Two vbx devices were deployed using kissing stent technique to pin the plaque (left: (b)(4), right: (b)(4)).On an unknown date in (b)(6) 2020, the patient presented with claudication in the right leg.Computer tomography angiography revealed the two vbx devices implanted utilizing the kissing stent technique had compressed.A thrombotic occlusion was observed in the right vbx device, and the left vbx device was compressed but patent.On (b)(6) 2020, the patient underwent reintervention.Thrombectomy of right vbx was performed.The compressed areas of both vbx devices were re-expanded using the kissing balloon technique.Two additional vbx devices were deployed utilizing the kissing stent technique.The patient tolerated the procedure.

Event Description

The following information was reported to gore: on (b)(6) 2020, the patient presented with total occlusion in the left common iliac artery and underwent treatment utilizing four gore® viabahn® vbx balloon expandable endoprosthesis (vbx).Two vbx devices were deployed using kissing stent technique to pin the plaque (left: 20702116, right: 21256447).On an unknown date in (b)(6) 2020, the patient presented with claudication in the right leg.Computer tomography angiography revealed the two vbx devices implanted utilizing the kissing stent technique had compressed.A thrombotic occlusion was observed in the right vbx device, and the left vbx device was compressed but patent.On (b)(6) 2020, the patient underwent reintervention.Thrombectomy of right vbx was performed.The compressed areas of both vbx devices were re-expanded using the kissing balloon technique.Two additional vbx devices were deployed utilizing the kissing stent technique.The patient tolerated the procedure.

Manufacturer Narrative

Follow-up report being sent to reflect completed investigation.Clinical code: (b)(4) appropriate term/code not available: device compressed but patent.Device code: (b)(4) appropriate term/code not available: device compression.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.

Manufacturer Narrative

H6 investigation findings code: 213.Engineering evaluation: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Crush resistance of the vbx device can be influenced by the stent ring material, stent ring geometry, stent ring spacing, and stent ring alignment.The stent rings are certified by the supplier for the material and geometric properties.Stent rings are 100% verified during the manufacturing process to be free of visual deformities.Stent ring geometry, spacing, and alignment are 100% verified during the manufacturing process.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.

Event Description

The following information was reported to gore: on (b)(6) 2020, the patient presented with total occlusion in the left common iliac artery and underwent treatment utilizing four gore® viabahn® vbx balloon expandable endoprosthesis (vbx).Two vbx devices were deployed using kissing stent technique to pin the plaque (left: 20702116, right: 21256447).On an unknown date in (b)(6) 2020, the patient presented with claudication in the right leg.Computer tomography angiography revealed the two vbx devices implanted utilizing the kissing stent technique had compressed.A thrombotic occlusion was observed in the right vbx device, and the left vbx device was compressed but patent.On (b)(6) 2020, the patient underwent reintervention.Thrombectomy of right vbx was performed.The compressed areas of both vbx devices were re-expanded using the kissing balloon technique.Two additional vbx devices were deployed utilizing the kissing stent technique.The patient tolerated the procedure.

Manufacturer Narrative

H6 clinical code: 3191-appropriate term/code not available: patient underwent reintervention.H6 device code: 3191-appropriate term/code not available: device compression.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
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10900437
• MDR Text Key: 218209225
• Report Number: 2017233-2020-01489
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Catalogue Number: BXA075901J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR