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

Catalog Number VBJR082502A

Device Problems Deformation Due to Compressive Stress (2889); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.Examination of the returned device revealed there was a kink in the distal shaft, upon which the endoprosthesis is mounted, at the transition.Approximately 4 cm of the endoprosthesis was expanded near the distal/tip end of the device.The remainder of the endoprosthesis remained constrained.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.(b)(4).

Event Description

The following was reported to gore: the gore® viabahn® endoprosthesis (lot #15755650, vbjr082502a) was placed over a.035 amplaz stiff wire and delivered through a 7fr sheath up and over the bifurcation to the distal sfa/popliteal region.The doctor began to deploy the gore® viabahn® endoprosthesis but the device did not deploy.The doctor noted there was tension while pulling the deployment line so decided to remove the device from the patient.The device was removed without incident and returned for examination.

Manufacturer Narrative

Upon further review of the event, it is determined that this event is not reportable.The device was partially deployed on the back table when the tech grabbed it after being removed from the patient.Device expansion outside the patient's body is not reportable.This report will be retracted.

• 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7283034
• MDR Text Key: 100657991
• Report Number: 2017233-2018-00119
• 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
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2019
• Device Catalogue Number: VBJR082502A
• Device Lot Number: 15755650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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 Outcome(s): Other
• Patient Age: 78 YR