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

Catalog Number PAH131002E

Device Problems Break (1069); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/10/2020

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

It was reported to gore that patient underwent endovascular treatment for an aneurysm of the right common iliac artery (cia) with an occluded external iliac artery (eia) and superficial femoral artery (sfa) using a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated that some years ago the patient has received an infrarenal tube graft.The physician decided to place an excluder stent graft with the main body from the left side and a viabahn-device of 13/10 followed by a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device) into the right internal iliac artery (iia) over an axillary access.The placement of the main body was no problem.The contralateral limb was cannulated from proximal with a terumo guidewire.This guidewire was changed to a cook rosen guidewire and a dsf1245 sheath was placed above the main body.It was reported that now the viabahn-device of 13/10 was brought into the contralateral leg with the proximal end at the level of contralateral marker of the excluder main body.The viabahn-device was opened, but there was resistance at the end of the deployment process.The deployment line did not detach of the product/catheter.Even with more force it was not possible to pull out the deployment line of the viabahn-device.It was stated that after some trials the deployment line disrupted.The catheter and sheath were removed, and some centimeters of the deployment line was visible outside the patient¿s body.Reportedly, it was decided not to pull again at the suture line in this position but to introduce another long 12 fr sheath to finish the case.With the new sheath, two vbx-devices were inserted to extend the viabahn-device into the right iia.It was stated that due to the manipulation of the viabahn-device the situation at the level of the contralateral limb into the viabahn-device did not seem to be save (not enough overlap anymore).The physician decided to balloon this segment and to place an advanta v12 stent graft 12/41 to secure this area.Finally, the result showed no endoleaks and open stent grafts on both sides.At this moment it was not clear, where the long part of the suture line is and if it will cause problems in the future.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Imaging evaluation: - there appears to be a vbh within the excluder contralateral gate.- the non-dicom image provided contains no patient/study demographics.- it appears that the proximal vbh device does not completely appose the contralateral gate.- the proximal end appears to be slightly below the excluder fd contralateral marker.The exact distance below the excluder flow divider is unknown as it is difficult to visualize using this unidentified and incomplete image source.- the excluder ipsilateral leg appears undeployed and within the sheath at this undefined time-point.Product investigation report conclusion: the manufacturing records were reviewed and the device lot met all pre-release specifications.The physical investigation of the device confirmed the physician¿s observation that the deployment line fibers were broken.The root cause for the deployment line resistance could not be determined with the currently available information.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN 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 Key: 10957457
• MDR Text Key: 222937229
• Report Number: 2017233-2020-01505
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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 Date: 01/01/2023
• Device Catalogue Number: PAH131002E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCLUDER STENTGRAFT
• Patient Age: 76 YR
• Patient Weight: 68