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

Model Number VBH100502A

Device Problems Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)

Patient Problems Aneurysm (1708); Insufficient Information (4580)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

During treatment of a splenic aneurysm, a gore® viabahn® endoprosthesis (viabahn device) did not advance to the splenic artery due to tortuous anatomy.Attempts were made to withdraw the viabahn device through the 12fr cook sheath; however, the device could not be withdrawn.The device was deployed in the gastroduodenal artery and the deployment line was pulled out.However, the delivery catheter became stuck and could not be removed.Decision was made to have the transplant surgeon cut and remove the delivery catheter during a scheduled renal transplant surgery on (b)(6) 2020.(b)(4).

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release manufacturing specification.A product history review was conducted for the vbx device, and manufacturing records show the device lot met all pre-release specifications.This evaluation follows the complaint detail to confirm failure to advance and difficulty during withdrawal.Both are likely the result of tortuous anatomy; further causal identification is not possible.

• 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
• MDR Report Key: 11335205
• MDR Text Key: 232164387
• Report Number: 2017233-2021-01679
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623211
• UDI-Public: 00733132623211
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2023
• Device Model Number: VBH100502A
• Device Catalogue Number: VBH100502A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 31 YR