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

Catalog Number JHJR070502J

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 07/15/2020

Event Type  Injury  

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

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 internal bleeding and went into shock.The patient's condition was stabilized by blood transfusion and bleeding control.An endoscopy confirmed that the vsx device protruding outside the vessel broke through the adjacent intestinal wall and protruded into the intestinal tract approximately 15mm.Additional treatment is planned as soon as the patient's condition improves.The physician reported that the vessel and intestinal wall were weakened due to pancreatic fluid leakage after the pancreaticoduodenectomy but the cause of breaking through the intestinal wall is unknown.

Manufacturer Narrative

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.

• 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: 10408840
• MDR Text Key: 203112335
• Report Number: 2017233-2020-01131
• 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?: Yes
• 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: 08/14/2020
• 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