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

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

Patient Problem Stenosis (2263)

Event Date 05/26/2021

Event Type  Injury  

Event Description

The following information was received through literature ¿preventive covered stent placement at the gastroduodenal artery stump in angiogram-negative sentinel hemorrhage after pancreaticoduodenectomy¿ published in abdominal radiology in 2021.The study aimed to evaluate the clinical outcomes of preventive covered stent placement at the gastroduodenal artery stump in patients with angiogram-negative sentinel hemorrhage after pancreaticoduodenectomy.Between july 2006 and september 2018, a total of 25 patients were evaluated, including 15 patients underwent preventive covered stent placement at the gastroduodenal artery stump and 10 patients received conservative treatments.Viabahn devices were used for patient 8 to 15.Patient 9, a (b)(6) woman experienced occlusion of the covered stent 112 days after the procedure.

Manufacturer Narrative

Article citation: title: preventive covered stent placement at the gastroduodenal artery stump in angiogram-negative sentinel hemorrhage after pancreaticoduodenectomy author yuan-mao lin, et al.Https://doi.Org/10.1007/s00261-021-03123-7.Abdominal radiology (2021) 46:4995¿5006.Patient weight was unavailable.Implant date was unavailable.A review of the manufacturing records for the device was unable to be conducted as no lot number was available.The device was not returned, and information was not made available, therefore, the device was not able to be evaluated.It is unknown if these adverse events were related to the viabahn devices.Information was not made available.Cause of the event cannot be established based on the available information.Further information regarding this event was requested by gore, but no further information has been reported.Cbas® heparin surface incorporates cbas-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 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14285417
• MDR Text Key: 290774760
• Report Number: 2017233-2022-02897
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• 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
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58
• Patient Sex: Female