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

Catalog Number VBC100502A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.An engineering evaluation is currently in progress.

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient was treated for a basilic vein thrombotic stenosis with a gore® viabahn® endoprosthesis.The device was advanced over a roadrunner wire through an 11fr terumo 10cm sheath.Deployment was initiated and the device expanded partially but not completely.This device was removed and a plan was made for the patient to return for further treatment.The patient is doing well.

Manufacturer Narrative

The engineering evaluation stated the following: the endoprosthesis was still mounted on the distal shaft, partially deployed.Approximately 40mm of the endoprosthesis was fully expanded.Approximately 7mm of the endoprosthesis remained constrained by the inner braided constraining line.The fourth and fifth strut rows from the distal end of the device appear to be unattached to the endoprosthesis.The end tape on these strut rows appeared to be displaced and detached.The first strut row from the proximal end of the device appeared to be outwardly bent.There was approximately 410mm of the deployment line between the hub and knob.Further deployment was able to be continued with traction on the deployment line at the proximal end of the endoprosthesis.The remainder of the device appeared unremarkable.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6986139
• MDR Text Key: 91351898
• Report Number: 2017233-2017-00567
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2019
• Device Catalogue Number: VBC100502A
• Device Lot Number: 16237767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 112