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

Catalog Number VBC100502A

Device Problems Device Slipped (1584); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Instructions for use precautions and directions for use sections state, once deployment is started, repositioning the endoprosthesis should not be attempted.

Event Description

As reported to gore, a patient presented with a stenosis in the patient's basilic vein.A 10 mm x 5 cm gore® viabahn® endoprosthesis was deployed with no issues at the intended treatment site.An 11fr sheath was used to advance a second 10 mm x 5 cm gore® viabahn® endoprosthesis over a.035 glidewire to overlap the first device.As deployment was started, the viabahn device moved forward, further into the previously placed viabahn device.The physician tried to reposition the partially deployed viabahn device by pulling on the catheter.The device fully expanded at the intended site.It was reported the deployment line appeared to be pulling on the newly deployed 10 mm x 5 cm viabahn device and would not complete its detachment from the endoprosthesis.A 10 mm x 4 cm balloon was used to anchor the viabahn device while the deployment line was pulled.Eventually, the line was released and the deployment line was completely removed from the patient.During the completion angiography, the device appeared to be fractured about 7 mm from the device edge.A non-gore device was placed inside the viabahn device to cover the fracture.The patient is reported to be doing well following the procedure.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7042316
• MDR Text Key: 93224158
• Report Number: 2017233-2017-00608
• 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
• Report Date: 10/23/2017

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: 07/13/2018
• Device Catalogue Number: VBC100502A
• Device Lot Number: 14230732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• 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: 41 YR