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

Catalog Number VBH100502A

Device Problems Material Separation (1562); Use of Device Problem (1670)

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

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the gore® viabahn® endoprosthesis instructions for use (ifu) special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was undergoing a procedure for arterio-venous access in the upper arm with a gore® viabahn® endoprosthesis.The access vessel was pre-dilated with an 8fr sheath, then the sheath was removed.An attempt was made to advance the device without a sheath in place, but it could not be advanced.The delivery system with the undeployed stent was removed from the patient.Upon removal, it was noted the leading olive tip was missing from the delivery catheter.A conversion to open repair ensued.The olive tip was not positively identified, but the surgeon believes the tip was removed in the process of suctioning and cleaning up the operative site.The patient tolerated the procedure.

Manufacturer Narrative

Results code 2: 213 updated: the following observations were made: the device was returned with a guidewire, which was not evaluated as it is not a gore device.The endoprosthesis was completely deployed/expanded and separate from catheter.The stent row on the scalloped end of the endoprosthesis was torn from the graft.Another portion of the stent is torn from the graft at approximately 1 cm from the straight end of the device.Connected to the deployment knob, there was 121 cm of deployment line with two fibers extending an additional 10 cm.There is a second portion of deployment line that measures approximately 32cm with 1 fiber extending an additional 7cm, and another fiber extending 13cm.There is a kink in the dual lumen catheter shaft at approximately 78 cm from the hub.The distal shaft, upon which the endoprosthesis was mounted, appears to be broken at 3.8cm from the transition.The remainder of the distal shaft and the distal tip were not returned.Conclusion code 2: updated.

Manufacturer Narrative

Results code 2: 213: the engineering evaluation stated the following: the device was returned with a guidewire, which was not evaluated as it is not a gore device.The endoprosthesis was completely deployed/expanded and separate from catheter.The stent row on the scalloped end of the endoprosthesis was detached from the graft.Another portion of the stent is disconnected from the graft at approximately 1 cm from the straight end of the device.Connected to the deployment knob, there was 121 cm of deployment line with two fibers extending an additional 10 cm.There is a second portion of deployment line that measures approximately 32cm with 1 fiber extending an additional 7cm, and another fiber extending 13cm.There is a kink in the dual lumen catheter shaft at approximately 78 cm from the hub.The distal shaft, upon which the endoprosthesis was mounted, appears to be broken at 3.8cm from the transition.The remainder of the distal shaft and the distal tip were not returned.Engineering evaluation conclusions are: based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7852965
• MDR Text Key: 119529608
• Report Number: 2017233-2018-00546
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623211
• UDI-Public: 00733132623211
• 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,Followup
• Report Date: 03/07/2019

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: 06/14/2020
• Device Catalogue Number: VBH100502A
• Device Lot Number: 16615485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/04/2018; 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 88