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

Device Problem Complete Blockage (1094)

Patient Problems Death (1802); Ischemia (1942); Renal Failure (2041); Multiple Organ Failure (3261)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).No udi information is available since the requested lot number remains unknown.Literature citation: silverberg d, rimon u, raskin d, halak m.Long parallel stent grafts for the treatment of complex aortic aneurysms.Cardiovascular & interventional radiology 2018;41(4):537-543.The mean age of the patients in this article is used as the patient age.The publication date is being used as the date of event.

Event Description

The following information was reported to gore: in a literature article titled long parallel stent grafts for the treatment of complex aortic aneurysms, it states gore® viabahn® endoprostheses were used in chimney technique combined with aortic devices to treat aortic aneurysms.Eighteen patients were treated.Each viabahn was reinforced with a bare metal stent.One patient suffered spinal cord ischemia, despite having a spinal drain placed prior to surgery.She went on to develop acute renal failure and an occlusion of her left renal artery chimney, sepsis and eventually expired from multiorgan failure.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7438309
• MDR Text Key: 105755150
• Report Number: 2017233-2018-00225
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• 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 This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 71 YR