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

Device Problem Leak/Splash (1354)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Swelling (2091)

Event Date 03/01/2015

Event Type  Injury  

Event Description

During an abstract review, ("a novel approach to the management of carotid blowout syndrome: the use of thrombin in acase of failed stenting," journal of investigative medicine & volume 63, number 3, march 2015, authors: naveen sablani1, gary jain2, karthikeyan arcot1, jeffrey farkas) a method for treatment was described.As stated, "an (b)(6) male with a past medical history(pmh) significant for hypertension, coronary artery disease, abdominal aortic aneurysm and right carotid endarterectomy presented with dysphagia for 3 days with an expanding and painful pulsatile mass over his right neck.A computerized tomography angiogram of the neck showed a 6.8 x 6.1 x 4.5 cm expanding pseudo-aneurysm at the bulb of the right internal carotid artery (ica).Two covered stents (gore\ viabahn\) were placed in the right ica with a significant decrease in flow to the (pas).Follow-up carotid doppler showed a significant increase in flow into the pas the next day.A third viabahn\ stent was placed to provide coverage at the site of the leak but filling into the pas continued.As an alternative approach, thrombin was injected percutaneously into the pas under fluoroscopy, with simultaneous balloon occlusion of the stent.".

Manufacturer Narrative

No testing methods performed (lot number not reported).No results available since no evaluation performed.Three devices were involved in this article which required reintervention: device #1 - unknown lot number - mfr report #2017233-2015-00467, device #2 - unknown lot number - mfr report #2017233-2015-00468, device #3 - unknown lot number - mfr report #2017233-2015-00490.

• 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 86004 ; 9285263030
• MDR Report Key: 4957045
• MDR Text Key: 6253929
• Report Number: 2017233-2015-00490
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• 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
• 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: 86 YR