MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number VBC100502

Device Problem Insufficient Information (3190)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be performed as device item/lot numbers were not available.The images and device were no available , the imaging evaluation and engineering evaluation could not be performed.Two lot numbers were provided, only one device was involved in the reported issue.It was unknown which device was involved in the event.In this event, the second lot number was vbc100502/14197479.

Event Description

The following publication was reviewed: "combined surgical and endovascular treatment with arch preservation of acute debakey type i aortic dissection" received through "journal of chinese medical association.(2019) 82: 209-214".The author: chiao-po hsu, chun-yang huang, hsiang-ting chend.The hospital: surgery, department of surgery, taipei veterans general hospital, taipei, taiwan, roc; department of surgery, taoyuan general hospital, ministry of health and welfare, taoyuan, taiwan, roc; department of nursing, taipei veterans general hospital, taipei, taiwan, roc.The article includes the following case: between december 2011 and december 2015, 12 patients with type i aortic dissection concomitant involving supraaortic vessels underwent ascending aortic replacement and simultaneous stent grafts inserted into the descending aorta, left subclavian, and left carotid arteries, and into the innominate artery when possible, without arch replacement.The stent grafts, gore tag thoracic endoprosthesis and viabahn, were deployed under visual guidance through opened aortic arch into the true lumen, with the techniques of circulatory arrest, moderate hypothermia, and bilateral antegrade cerebral perfusion.Reported results stated the j-curved guide wire with 5 cm viabahn was cannulated into the left subclavian artery (lsa) but kept in situ without deployment (usually 1.5 cm of covered stent was protruded into the arch lumen).Finally, remaining viabahn was deployed in the lsa.During 1-year postoperative follow-up, only one of 26 covered stents placed in supra-aortic branches showed thrombosis and occlusion.This stent was in the lsa, which did not cause obvious symptoms.

Manufacturer Narrative

H6 - code 213: review of device manufacturing record history confirmed both devices met pre-release specifications.Two lot numbers were provided by user facility.Only one gore® viabahn® endoprosthesis was involved in the reported issue and it is unknown which device was involved in the reported occlusion event.The second device lot number that was provided is: lot number 14197479; item number vbc100502.

Manufacturer Narrative

A2.Age at time of event, a3.Sex and a4 (lot# and catalog#)were updated.The article stated 5cm gore® viabahn® endoprosthesis into the left subclavian artery (lsa), therefore the device lot number was 14197479, item number was vbc100502.According to table 1 in the article, this was patient 5( female; 71 year old with aberrant right subclavian artery).

Manufacturer Narrative

Section d and h4 were updated with suspect medical device product information.Two device lot numbers were provided by user facility.Only one gore® viabahn® endoprosthesis was involved in the reported issue and it is unknown which device was involved in the reported event.Further review of the article seem to confirm a 5cm gore® viabahn® endoprosthesis was implanted in the patient's left subclavian artery (lsa).Therefore, the device lot number is updated to 14197479, item number was vbc100502.Mfr report# 2017233-2019-00848 was also reported based on this article.The same device lot number is used because we were unable to confirm with user facility which device was involved in this event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9068747
• MDR Text Key: 161937765
• Report Number: 2017233-2019-00860
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/22/2019

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: 07/06/2018
• Device Catalogue Number: VBC100502
• Device Lot Number: 14236013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/20/2019; 09/24/2019; 10/08/2019; 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR