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

Model Number	BXA097902A
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Concomitant medical products and therapy dates: calcium, fish oil, lysine, niacin, vitamin b and c.
Event or Problem Description
On (b)(6) 2020 the patient underwent endovascular treatment of an aortic aneurysm using investigational tambe devices.Two gore® viabahn® vbx balloon expandable endoprostheses (vbx) were utilized in the patient's superior mesenteric artery (sma).On (b)(6) 2020 branch stenosis of the sma was observed at the transition between the aortic segment and the branch vessel segment in the bridging vbx device.It was reportedly suspected that the cause of the stenosis was the investigational tambe device ¿settling¿ into its final seal position which may have resulted in slight kinking of the sma branch stent.Blood flow was reportedly present.On the same day balloon angioplasty, stenting, and selective angiography of the sma via left brachial cutdown and second order cannulation of the sma was performed.The adverse event was deemed resolved on (b)(6) 2020.There were no further reported issues.
Additional Manufacturer Narrative
H6.Investigation findings: code 213 the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), hazards and adverse events that may occur include, but are not limited to, device related stenosis.H6.Investigation findings: code 3233 updated to code 213.H6.Investigation conclusions: code 11 updated to code 4315.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12549257
• Report Number: 2017233-2021-02412
• Device Sequence Number: 17423714
• Product Code: PRL
• UDI-Device Identifier: 00733132637607
• UDI-Public: 00733132637607
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: BXA097902A
• Device Catalogue Number: BXA097902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 109