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

Catalog Number VBHR080702A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

Event 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advancement it appeared that the gore® viabahn® endoprosthesis with heparin 'accordioned'.The cook device was withdrawn and the doctor observed that the gore® viabahn® endoprosthesis with heparin was attached to it.The absence of the gore® viabahn® endoprosthesis with heparin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.

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
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7906261
• MDR Text Key: 121616364
• Report Number: 2017233-2018-00569
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132624065
• UDI-Public: 00733132624065
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR