MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Ischemia (1942); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device lot number information was requested, but not made available.Therefore, no review of the manufacturing paperwork could be performed.The device remains implanted.Therefore, direct product analysis was not possible.Instructions for use warnings states, w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral, iliac arteries or the venous anastomosis of the arteriovenous (av) access circuit.Special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.Sizing table states, recommended endoprosthesis compression within the vessel is approximately 5 ¿ 20%.

Event Description

Reviewed was publication, "common femoral vein stent placement in a frozen abdomen causing acute limb ischemia", authors kathleen m.Lamb, md, julia glaser, md, phillip dowzicky, md, and paul j.Foley, md, philadelphia, pa.(j vasc surg cases and innovative techniques 2017;3:63-5.) a patient with a history of metastatic anal carcinoma was admitted for left groin hemorrhage and an acute drop in hemoglobin level at the site of a fungating tumor of perianal squamous cell carcinoma.The patient previously had chemotherapy treatment and had received palliative pelvic irradiation in the left leg.Computed tomography (ct) scan showed the femoral vein was the source of the bleeding.From the left popliteal vein, a 12f sheath was used to place a 13x5 gore® viabahn® endoprosthesis at the left distal external iliac/common femoral vein.As reported, the vein measured 7.4 mm before placement of a 13mm device.A 12mm angioplasty balloon was used for post dilation.The hemorrhage stopped with the device placement.On completion venography, thrombus was noted in the common femoral vein, requiring angiojet and percutaneous thrombectomy of the common iliac vein.Immediately after the procedure, the patient had left leg pain and decreased sensation in the foot.Ct angiography revealed patent vessels, but mass effect on the left external iliac and common femoral arteries from the left common femoral vein stent.The patient was heparinized and taken to the operating room.Through the right common iliac artery access, diagnostic arteriography revealed stenosis of the left common iliac and external iliac arteries.A 7x10 gore® viabahn® endoprosthesis was placed into the left external iliac artery.It was stated the patient¿s lower extremity compartments remained soft after revascularization.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6950266
• MDR Text Key: 89342805
• Report Number: 2017233-2017-00538
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2017

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: 10/13/2017
• 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): Required Intervention
• Patient Age: 73 YR