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

Catalog Number	VBH130202A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of device manufacturing record history confirmed device met pre-release specifications.The engineering evaluation state the deployment knob and deployment line coming from the hub were not returned to gore.The distal end of the endoprosthesis was expanded approximately 3 cm.Approximately 6 cm of columnar failure of the dual lumen catheter shaft was present 3.5 cm from deployment hub.Based on the device examination performed, no manufacturing anomalies were identified.Instructions for use for gore® viabahn® endoprosthesis with heparin bioactive surface state: intended use / indications: the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 ¿ 6.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 ¿ 12 mm.The gore® viabahn® endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (av) access grafts.Warnings section state: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral, iliac arteries or the venous anastomosis of the arteriovenous (av) access circuit.Do not attempt to deploy the endoprosthesis or manipulate the delivery system without an appropriately sized guidewire and fluoroscopic guidance.
Event or Problem Description
The following was reported to gore: an open elephant trunk thoracic endo graft procedure was performed on (b)(6) 2018.It was reported that a sheath and guidewire were not used to advance the gore® viabahn® endoprosthesis.The viabahn device was inserted into the subclavian artery for perfusion.The deployment line snapped during deployment, resulting in a partially constrained viabahn device.The viabahn device was removed from patient with no issues, and a new viabahn device was inserted and deployed in the subclavian artery.It was reported the patient did not experience any adverse consequences.
Additional Manufacturer Narrative
D5 - updated with 'health professional' selection.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8250909
• Report Number: 2017233-2019-00035
• Device Sequence Number: 16542580
• Product Code: PFV
• UDI-Device Identifier: 00733132623273
• UDI-Public: 00733132623273
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2020
• Device Catalogue Number: VBH130202A
• Device Lot Number: 17911100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1