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

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

No lot number reported.Therefore, no testing methods performed no results available since no evaluation performed.Imaging evaluation - there appear to be 2 different types of devices in the image.One non-gore device (manufacture unknown) and a gore viabahn® endoprosthesis.There does not appear to be any anatomical landmarks or vessels in the image.In the gore viabahn® endoprosthesis on the right there appears to be multiple disruptions in the wire pattern of the device.The disruptions appear worse immediately after the overlap of the gore/non-gore devices in this image that appears at the bend of the device.There are several wire ends identified these appear to represent multiple fractures.As indicated in the device's instructions for use warning section, "w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis with heparin bioactive surface in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.".

Event Description

As reported, a gore viabahn endoprosthesis was implanted for the treatment of a popliteal artery aneurysm.Approximately a year later, imaging revealed apparent device thrombosis and a possible stent wire fracture the device.On (b)(6) 2015, the device was explanted.The device was initially implanted in a different hospital by a different vascular surgeon.

Manufacturer Narrative

Additional information: (b)(6).

Manufacturer Narrative

Device evaluated by manufacturer? previous reports were blank.Corrected information-not returned to manufacture.

• 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: roger smith ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5226981
• MDR Text Key: 31335600
• Report Number: 2017233-2015-00794
• 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,Followup,Followup
• Report Date: 11/19/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/17/2015; 11/20/2015
• 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: 81 YR
• Patient Weight: 82