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

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the devices could not be conducted because the lot numbers remain unknown.Further information was requested and will be provided.Please note that the article ¿peripheral stent thrombosis leading to acute limb ischemia and major amputation: incidence and risk factors in the aortoiliac and femoropopliteal arteries ¿ (cardiovasc intervent radiol p.351¿359, konstantinos katsanos, said a.M.Al-lamki, aneeta parthipun, stavros spiliopoulos, sanjay dhanji patel, ioannis paraskevopoulos, hany zayed and athanasios diamantopoulo).The date of publication was used as the date of incident.

Event Description

In review of published literature, these findings were noted.In a literature article titled ¿peripheral stent thrombosis leading to acute limb ischemia and major amputation: incidence and risk factors in the aortoiliac and femoropopliteal arteries ¿ (cardiovasc intervent radiol p.351¿359, konstantinos katsanos, said a.M.Al-lamki, aneeta parthipun, stavros spiliopoulos, sanjay dhanji patel, ioannis paraskevopoulos, hany zayed and athanasios diamantopoulo) it states from 2009 to 2014, 256 patients (n=277 limbs) were analyzed over a 5 year period.Gore® viabahn® endoprostheses were utilized as well as gore® tigris® vascular stents.In the article was discussed that within the setting of acute stent thrombosis and acute limb ischemia (ali) presentation, four major amputations occurred within the first 2 months.The major amputation rate for gore® viabahn® endoprosthesis was 8.7%.The majority of the patients were treated due to chronic atherosclerotic disease (96%).

Manufacturer Narrative

Further information was requested and was not available.According to the gore® viabahn® endoprosthesis instructions for use (ifu), complications and adverse events can occur include, but are not limited to thrombosis or occlusion.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6749020
• MDR Text Key: 81230398
• Report Number: 2017233-2017-00386
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

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: Not provided
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/22/2017
• 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): Other
• Patient Age: 74 YR