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

Model Number	VBH100502A
Health Effect - Clinical Codes	Aneurysm (1708); Insufficient Information (4580)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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were made to withdraw the viabahn device through the 12fr cook sheath; however, the device could not be withdrawn.The device was deployed in the gastroduodenal artery and the deployment line was pulled out.However, the delivery catheter became stuck and could not be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).
Additional 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
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11335205
• Report Number: 2017233-2021-01679
• Device Sequence Number: 13667443
• Product Code: NIP
• UDI-Device Identifier: 00733132623211
• UDI-Public: 00733132623211
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2023
• Device Model Number: VBH100502A
• Device Catalogue Number: VBH100502A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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; Other
• Patient Age: 31 YR