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

Model Number	BXA083902A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially non-eluting.
Event or Problem Description
'chimney stent graft for left subclavian artery preservation during thoracic endograft placement' andre ramdon, mbbs, ramkrishna patel, md, jeffrey hnath, md, chin-chin yeh, md, and r.Clement darling iii, md, albany, ny.A retrospective review of a single vascular surgery registry between february 2011 and september 2017 was performed of all left subclavian revascularization during elective tevar.Arch reconstructions involving more than just the left subclavian artery were excluded.Indications, demographics, procedural details, and outcomes were analyzed using standard statistical analysis.There was one type ia or gutter leak detected few months after the study completion date (10 months after implantation) resulting from foreshortening of the vbx stent.The balloon-expandable 7-mm stent was ballooned to 8 mm during the initial case without any evidence of endoleak.In retrospect, the largest portion of the implanted vessel measured 11 mm.Because the stent co-opted to the native vessel, it lost some of the overlap with the tevar and hence the endoleak.This was treated with extension and redilation to appropriate size, with continued patency of the left vertebral artery.
Additional Manufacturer Narrative
This medwatch report is a duplication that has been captured on report number 2017233-2020-01217.

• 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: 11672702
• Report Number: 2017233-2021-01866
• Device Sequence Number: 11526229
• Product Code: PRL
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 05/15/2023
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/26/2021
• 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: Hospitalization; Other; Required Intervention