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

Model Number BXA083902A

Device Problem Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 09/01/2019

Event Type  Injury  

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 gore viabahn® vbx balloon expandable endoprostheses that were used as side branch components.A pre-ct, dated (b)(6) 2019, showed that the celiac artery was somewhat stenotic (diameter ostium 5.5 mm, diameter 15 mm distal 7.5 mm).Intraoperatively, the superior mesenteric artery (sma) branch was deployed prior to the celiac branch.When introducing the sheath and celiac branch component, initial resistance was felt which was believed to be due to stenosis at the celiac ostium.However, celiac branch components were successfully delivered and deployed.On (b)(6) 2019, it was identified that the sma branch was partially compressed/stenotic between the outlet of its portal on the tambe aortic component and the ostium of the sma.The causality cannot be confirmed, but it is suspected that this stenosis may have occurred when introducing and deploying the celiac branch components.Intravascular ultrasound (ivus) was utilized to determine the morphology of the sma stent stenosis.On (b)(6) 2019, two pta balloons were advanced into the celiac and sma branches.These balloons were inflated at the same time in a kissing fashion.No additional components were deployed.Repeat angiography and ivus of the sma stent revealed that the stenosis has greatly improved.The patient tolerated the procedure.

Manufacturer Narrative

G5: corrected combination product.H6: 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: 9321253
• MDR Text Key: 166527221
• Report Number: 2017233-2019-01137
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• 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

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Device Lot Number: 20941943
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 78