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

Catalog Number VBH130502A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982)

Event Date 11/25/2015

Event Type  Death  

Manufacturer Narrative

See report # 2017233-2015-00881 for second gore® viabahn® endoprosthesis lot# 11895780, (b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.Warnings section of ifu 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.

Event Description

On (b)(6) 2015, the patient presented for treatment of a proximal type i endoleak that was attributed to disease progression.At the beginning of the procedure, the innominate artery was dissected by a guidewire or catheter.Reportedly, the patient recently received radiation treatment in the neck, which may have compromised the artery.Two gore® viabahn® endoprostheses were deployed in the innominate artery to cover the dissection.The common carotid and vertebral arteries were intentionally covered as this time.Imaging confirmed a patent circle of willis with retrograde flow to the brain.The endoleak treatment continued and devices were placed in the renal arteries and the proximal section of the aorta.Final angiography showed good results with no evidence of endoleak.The patient tolerated the procedure, was responsive post-operatively, and showed no sign of stroke.During the night on (b)(6) 2015, the patient had a massive neurological event and expired.It is unknown what type of neurological event occurred.The gore® viabahn® endoprostheses placed in the innominate artery were patent at the time of patient's death.It was reported that the physician does not attribute the gore® viabahn® endoprostheses to the neurological event or death.An autopsy will not be performed.

• 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 86001
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5295783
• MDR Text Key: 33473622
• Report Number: 2017233-2015-00880
• Device Sequence Number: 1
• Product Code: NIP
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2015

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
• Device Expiration Date: 05/05/2018
• Device Catalogue Number: VBH130502A
• Device Lot Number: 13942962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• 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): Death
• Patient Age: 73 YR
• Patient Weight: 70