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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Fistula (1862)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following literature was reviewed: junzi ito, et al.Case report: migration of viabahn stent graft into intestinal tract a year after the placement.The official journal of the japanese society of interventional radiology.2021; 36 (suppl.): 218.A female patient in her 60s underwent pancreaticoduodenectomy for duodenal cancer.On the ninth postoperative day, a large amount of intra-abdominal hemorrhage was observed, and the patient went into hypovolemic shock.An angiography showed disruption from the common hepatic artery to the proper hepatic artery and active bleeding.A gore® viabahn® endoprosthesis was implanted in the disrupted area, and hemostasis was achieved.Afterwards, early occlusion of the stent graft lumen was noted, but blood flow in the hepatic artery was maintained by collateral pathways.The patient was treated for pancreatic fistula and was discharged 3 months after the procedure.After discharge from the hospital, the patient was regularly followed up with contrast-enhanced ct imaging.A ct scan about 10 months later showed that a part of the viabahn had migrated into the elevated jejunum, and a ct scan about 1 year later showed that the viabahn had disappeared from the implanted site and had migrated into the sigmoid colon.There were no obvious abdominal symptoms or signs of infection after the migration.

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.C1: name and manufacturer added h10: 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

Fields b1, d1 and d2 were updated as requested.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13519135
• MDR Text Key: 289345480
• Report Number: 2017233-2022-02740
• 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,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Female