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

Device Problem Insufficient Information (3190)

Patient Problems Not Applicable (3189); No Information (3190)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.No date of event was available, therefore the published date of the article was used.

Event Description

Within the article in the journal of vascular and interventional radiology (¿the "never-ending coil": embolization procedure complicated by an unraveled coil.¿) a case presentation is discussed.On an unknown date, the patient with a history of infrarenal abdominal aortic aneurysm treated 7 years previously with endovascular aneurysm repair presented with a ruptured aortic aneurysm sac.Computed tomography (ct) demonstrated a significant type ia endoleak, which was initially treated with a ¿chimney¿ consisting of two overlapping aortic cuffs (medtronic endurant ii) and a total of four gore® viabahn® endoprostheses (two in the right renal artery, one in the left renal artery and one in the superior mesenteric artery.Angiography after deployment of these devices showed a persistent type i endoleak between the superior aortic cuff and the right renal artery stent.The following day, the patient was treated with embolization of the endoleak using detachable coils.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: joerg kersten ; 9285263030
• MDR Report Key: 6967932
• MDR Text Key: 89922088
• Report Number: 2017233-2017-00545
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• 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: 78 YR