MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Model Number BXA077902A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

It was reported that on (b)(6) 2019, the patient presented with a thoracoabdominal aortic aneurysm (taaa) class iv that was successfully treated with a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) and several gore viabahn® vbx balloon expandable endoprostheses that were used as side branch components.During the procedure, an endoleak of unknown origin was visible.The left renal artery and the superior mesenteric artery (sma) were inspected at the time.On (b)(6) 2019, a type ic endoleak at the renal artery side branch vbx was identified.On (b)(6) 2019, the endoleak was successfully treated with balloon angioplasty and the implantation of an additional vbx.Selection angiography was re-performed and the absence of the endoleak following the additional stent placement confirmed.The patient tolerated the procedure.

Manufacturer Narrative

Updated result code 1 / conclusion code 1.Code 213- the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

D2: corrected.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9374035
• MDR Text Key: 176983129
• Report Number: 2017233-2019-01186
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: 00733132637539
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2020

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: 06/18/2022
• Device Model Number: BXA077902A
• Device Catalogue Number: BXA077902A
• Device Lot Number: 20912579
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2019; 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 123