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

Catalog Number VBC081002

Device Problems Break (1069); Failure to Deliver (2338)

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

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot/serial: (b)(4) = udi: (b)(4).The review of the manufacturing records verified that the lots met all pre-release specifications.

Event Description

It was reported to gore that a 8mm x 10cm gore® viabahn® endoprothesis was to be implanted for av revision in the left forearm.The viabahn® device was advanced over a 0.035 terumo stiff guide wire through a 10fr terumo sheath to the target lesion and initiated deployment.However it was stated the viabahn® device was not fully expanded after the deployment line was pulled out from the catheter.The deployment line seemed broken.A cut-down from the brachial artery below elbow was performed to remove the partially expanded viabahn® device together with the sheath out of the patient.Then a new viabahn® device was used to continue the procedure successfully without any reported issue to the patient.

Manufacturer Narrative

The device was returned for analysis.The engineering evaluation result stated that no knob nor connected deployment line was returned.At approximately 3 cm from hub, there was columnar failure of dual lumen.There was 1 cm of dual lumen stretched out near the transition.Approximately 5 cm of distal shaft, upon which the endoprosthesis is mounted, was exposed at transition.The endoprosthesis was longitudinally compressed and displaced on shaft towards the tip.The outer braided constraining line was completely deployed with approximately 1 cm of the inner braided constraining line deployed.The endoprosthesis was partially expanded with approximately 5.7 cm of endoprosthesis still constrained.The deployment line connected to the endoprosthesis went into the transition port.There was a broken fiber in the deployment line approximately 12 cm from endoprosthesis.Deployment was able to be continued with traction of the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.Per the gore® viabahn® endoprosthesis instructions for use (ifu), it is stated that complications and adverse events that can occur when using any endovascular device.These complications include but are not limited to deployment failure.A warning is given as ¿inadvertent, partial, or failed deployment of the endoprosthesis may require surgical intervention.¿.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7590332
• MDR Text Key: 110713415
• Report Number: 2017233-2018-00325
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2020
• Device Catalogue Number: VBC081002
• Device Lot Number: 17442001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR