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

Catalog Number JHJR060202J

Device Problem Insufficient Information (3190)

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 08/26/2021

Event Type  Injury  

Event Description

The following literature was reviewed: hiroshi miura, et al.A successful case of viabahn placement in emergency ivr for postoperative bleeding from pancreatic head cancer.Program and abstracts of the 57th autumn assembly of the japan radiological society.2021; s467.A woman in her 70s had massive bleeding through drainage on the 9th day after surgery for pancreatic head cancer.An angiography showed spasm in the hepatic artery, and pseudoaneurysm formation and extravasation were also noted.Hemostasis was attempted for a temporal period using a micro-balloon catheter (attendant® 4mm) and the shrinkage of the hepatic artery was improved.A destination® (90 cm) sheath was inserted into the origin of the celiac artery via the left brachial artery because it was difficult to advance the device via the aorta for an anatomical reason.Gore® viabahn® endoprosthesis (6 mm x 25 mm) was implanted using a v-18 guidewire into the hepatic artery.An immediate angiography showed disappearance of the pseudoaneurysm and preservation of the hepatic artery blood flow.On an unknown date, a follow-up ct scan showed no recurrence of the pseudoaneurysm, but the viabahn® was occluded and infarction was observed in the lateral zone of the left hepatic lobe.After 2 months of treatment, the patient was discharged from the hospital.Emergency viabahn® implantation for postoperative bleeding of biliary tract diseases may be an important lifesaving technique as interventional radiology (ivr).

Manufacturer Narrative

Date of publication was used for event date due to no implant date being provided.Due to an unknown lot/serial number and no device return, an investigation could not be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

" a successful case of viabahn placement in emergency ivr for postoperative bleeding from pancreatic head cancer." hiroshi miura, et al.Program and abstracts of the 57th autumn assembly of the japan radiological society.2021; s467.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13172123
• MDR Text Key: 286266558
• Report Number: 2017233-2022-02654
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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 Catalogue Number: JHJR060202J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Other
• Patient Age: 70 YR
• Patient Sex: Female