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

Catalog Number JHJR070502J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

Device lot number was requested but not made available, device remains implanted therefore further investigation cannot be conducted.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 was reported to gore: on an unknown date in (b)(6) 2020, the patient underwent treatment for a pancreaticoduodenectomy.On (b)(6) 2020, the patient underwent treatment for a rupture of the common hepatic artery due to pancreatic fluid leakage from the pancreaticoduodenectomy using a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx).On (b)(6) 2020, the patient presented with abdominal pain.Ct imaging revealed a pseudoaneurysm at the distal end of the vsx device.A coil embolization was performed from the distal side of the vsx device to the proper hepatic artery.The patient tolerated the procedure.Other: pseudoaneurysm.

Manufacturer Narrative

Added g3/g4, h1/h2, h6 and d4.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Corrected: a2: age at the time of event.

Manufacturer Narrative

Added g3/g4, h1/h2, h6 and h4/g5: manufacturer date.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10399554
• MDR Text Key: 203107968
• Report Number: 2017233-2020-01123
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

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: 01/17/2022
• Device Catalogue Number: JHJR070502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/27/2022; 10/27/2022
• Supplement Dates FDA Received: 10/13/2022; 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male