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

Catalog Number PAH131002

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a left iliac artery aneurysm with a gore® viabahn® endoprosthesis with propaten bioactive surface.The device was prepped per ifu.Access was obtained and the device was advanced over a.035" 190cm supracore wire through a 12 fr gore® dryseal flex sheath.However, midway through advancement in the sheath, the endoprosthesis became caught and it became dislodged from the delivery catheter.Additionally, part of the deployment line had come off the endoprosthesis.There was no unusual torquing or twisting of the delivery catheter reported.This device was not used.The ostium of the vessel was balloon dilated and the guidewire was exchanged for a.035" 300cm supracore wire.A new gore® viabahn® endoprosthesis with propaten bioactive surface was advanced and deployed successfully through the same sheath.

Event Description

On (b)(6) 2019 a patient was undergoing treatment of a left iliac artery aneurysm with a gore® viabahn® endoprosthesis with propaten bioactive surface.The device was prepped per ifu.Access was obtained and the device was advanced over a.035" 190cm supracore wire through a 12 fr gore® dryseal flex sheath.However, midway through advancement in the sheath, the endoprosthesis became caught and it became dislodged from the delivery catheter.Additionally, part of the deployment line had come off the endoprosthesis.There was no unusual torqueing or twisting of the delivery catheter reported.This device was not used.The ostium of the vessel was balloon dilated and the guidewire was exchanged for a.035" 300cm supracore wire.A new gore® viabahn® endoprosthesis with propaten bioactive surface was advanced and deployed successfully through the same sheath.

Manufacturer Narrative

B.5.Updated.H.6.Results code 2: 213: the engineering evaluation stated the following: the entire device was returned.The deployment line did not appear taut in the hub.Approximately 1.4cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed at the transition.The endoprosthesis was longitudinally compressed towards the tip end of the device.The endoprosthesis appeared to be damaged and contained outwardly flared struts approximately 2cm from the tip end of the device.The outer braided constraining line was deployed approximately 3.3cm.The remainder of the endoprosthesis was still constrained.The remainder of the device appeared unremarkable.No anomalies were found following an engineering evaluation.No manufacturing cause could be identified as a result of the investigation.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8913328
• MDR Text Key: 155187767
• Report Number: 2017233-2019-00678
• Device Sequence Number: 1
• Product Code: PFV
• 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: 10/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Catalogue Number: PAH131002
• Device Lot Number: 18068530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 70