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

Catalog Number	VBHR080702A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event or Problem Description
The following was reported to gore: the patient presented for a thoracic case.The gore® viabahn® endoprosthesis with heparin was placed in the left exterior iliac to the common iliac to be a conduit for the advancement of the cook device.The doctor reported the vessel was very tortuous.Next a cook alpha 34-113 (18fr-7.1mm) device was advanced to the gore® viabahn® endoprosthesis with heparin.Attempts to advance the cook device through the gore® viabahn® endoprosthesis with heparin were unsuccessful.During advancement it appeared that the gore® viabahn® endoprosthesis with heparin 'accordioned'.The cook device was withdrawn and the doctor observed that the gore® viabahn® endoprosthesis with heparin was attached to it.The absence of the gore® viabahn® endoprosthesis with heparin created an iliac rupture.Control of the rupture was achieved with a coda balloon.The iliac was repaired using multiple endovascular devices and the thoracic procedure was completed.The doctor reported to gore that the patient was in stable condition.
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing records indicated the device met pre-release specifications.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.Method code 2, results code 2.Corrected data: result code 1.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7906261
• Report Number: 2017233-2018-00569
• Device Sequence Number: 16596021
• Product Code: PFV
• UDI-Device Identifier: 00733132624065
• UDI-Public: 00733132624065
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/25/2018

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: 05/22/2021
• Device Catalogue Number: VBHR080702A
• Device Lot Number: 18360566
• Was Device Available for Evaluation?: No
• 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: 09/25/2018
• Supplement Report FDA Received Date: 09/26/2018
• 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: 67 YR