MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAJR081502E

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.Therefore, a device evaluation cannot be performed.(b)(6) 2020.The present event involves three gore devices and therefore three individual reports will be submitted with gore reference numbers (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

On (b)(6) 2019, the patient underwent endovascular treatment of a thoracoabdominal aneurysm type i with a gore® tag® thoracic branch endoprosthesis.To further provide blood flow to the left subclavian artery a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).Was implanted using a snorkel / chimney technique (sandwich).In the distal subclavian artery two gore® viabahn® endoprosthesis (viabahn device) with propaten bioactive surface were implanted.Percutaneous access was gained via the femoral artery.The devices were navigated to its intended location and deployed without issues.At the end of the procedure all devices were patent.Reportedly, on (b)(6) 2020, the vbx device and both viabahn devices have thrombosed for unknown reason.They stated, that the patient is asymptomatic.Therefore, neither surgical/endovascular treatment nor medication was required.

Event Description

On (b)(6) 2019, the patient underwent endovascular treatment of a thoracoabdominal aneurysm type i with a gore® tag® thoracic branch endoprosthesis.To further provide blood flow to the left subclavian artery a gore® viabahn® vbx balloon expandable endoprosthesis (viabahn®vbx device) was implanted using a snorkel / chimney technique (sandwich).In the distal subclavian artery two gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® device) were implanted.Percutaneous access was gained via the femoral artery.The devices were navigated to its intended location and deployed without issues.At the end of the procedure all devices were patent.Reportedly, on (b)(6) 2020, the viabahn® vbx device and both viabahn® devices have thrombosed for unknown reason.They stated, that the patient is asymptomatic.Therefore, neither surgical/endovascular treatment nor medication was required.

Manufacturer Narrative

H6-code 213: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The present event involves three gore devices and therefore three individual reports have been submitted with the following manufacturer report numbers: manufacturer report number 2017233-2021-01737 (s/n (b)(6) manufacturer report number 2017233-2021-01738 (s/n (b)(6) manufacturer report number 2017233-2021-01739 (s/n (b)(6) b4: updated event description g4: combination product: yes.H6: updated codes.

Event Description

On (b)(6) 2019, the patient underwent endovascular treatment of a thoracoabdominal aneurysm type i with a gore® tag® thoracic branch endoprosthesis.To further provide blood flow to the left subclavian artery a gore® viabahn® vbx balloon expandable endoprosthesis (viabahn®vbx device) was implanted using a snorkel / chimney technique (sandwich).In the distal subclavian artery two gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® device) were implanted.Percutaneous access was gained via the femoral artery.The devices were navigated to its intended location and deployed without issues.At the end of the procedure all devices were patent.Reportedly, on (b)(6) 2020, the viabahn® vbx device and both viabahn® devices have thrombosed and occluded for unknown reason.They stated, that the patient is asymptomatic.Therefore, neither surgical/endovascular treatment nor medication was required.

Manufacturer Narrative

B4: updated description: h6-code 4112: images have been provided for evaluation.H6-code 213: the imaging evaluation stated the following: ¿ three time-points available for evaluation: pre-implantation cta dated (b)(6) 2018, post-implantation cta dated (b)(6) 2019 and post-implantation dated (b)(6) 2020.¿ on the post-implantation images dated (b)(6) 2019: o there appears to be viabahn® device(s) in the lsa extending into the distal aortic arch and descending thoracic aorta.O from the lsa origin, the viabahn® devices appear to be on the outside of the 2 most proximal gore® tag® thoracic branch endoprosthesis device(s) and ¿sandwiched¿ between the proximal and distal gore® tag® thoracic branch endoprosthesis devices in the dta.O there appears to be a portion within the implanted viabahn® devices where the diameters narrow.O the length from the proximal end of the viabahn® device(s) in the lsa to a level where diameters start to be narrowed appears to be ~3.2cm.O the length of narrowed diameters within the implanted viabahn® devices appears to be ~3cm.Diameters appear to range from ~1.5mm ¿ 4.0mm within narrowed portion of devices.O the angulation within this narrowed portion of device(s) appears to be more than 100 degrees.O all implanted devices on this time-point appear to be patent.¿ on the post-implantation images dated (b)(6) 2020: o cpr and mpr views appear to show occlusion of the implanted viabahn® devices.¿ on comparison axial images of the (b)(6) 2019 and (b)(6) 2020 studies: o contrast can be visualized proximal to the viabahn® devices in the lsa on both time-points.O the narrowed portion of the viabahn® devices appears to be the same on both time-points.O there appears to be flow within all the implanted devices on (b)(6) 2019.O on the (b)(6) 2020 images the viabahn® devices appear to be occluded.

Manufacturer Narrative

H6-code 213: a review of the manufacturing records indicate the lot met all pre-release specifications.A review of the sterilization records indicate the lot met all pre-release specifications.A review of the heparin coating paperwork indicate the lot met all pre-release specifications.

Manufacturer Narrative

Added component code.H6: code 22: in the instructions for use, section "hazards and adverse events", the following is stated: procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: occlusion; device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: occlusion.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11421951
• MDR Text Key: 238593254
• Report Number: 2017233-2021-01739
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2021
• Device Catalogue Number: PAJR081502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 62 KG