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

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

¿four cases that was treated of postoperative bleeding due to pancreatic fistula using viabahn stent¿ (nobuyasu suzuki, et.Al., general meeting of the japanese society of gastroenterology surgery, 2020(75), p313-4 ).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 literature was reviewed ¿four cases that was treated of postoperative bleeding due to pancreatic fistula using viabahn stent¿ (nobuyasu suzuki, et.Al., general meeting of the japanese society of gastroenterology surgery, 2020(75), p313-4 ).Case 1: a (b)(6) male underwent pylorus-preserving pancreatoduodenectomy to treat a pancreatic head cancer.A pancreatic fistula was observed postoperatively, and hemorrhage from the common hepatic artery aneurysm was observed on the 17th postoperative day.A gore® viabahn® endoprosthesis with heparin bioactive surface was successfully placed to treat the bleeding.At an unknown time after the procedure, stent graft occlusion was confirmed.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11959849
• MDR Text Key: 254920855
• Report Number: 2017233-2021-02065
• 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
• Report Date: 06/08/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR