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

Catalog Number VBH130502W

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.Intended use / indications the gore® viabahn® endoprosthesis with heparin bioactive surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0¿12 mm.Warnings ¿ w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis with heparin bioactive surface in applications other than the endovascular grafting of superficial femoral or iliac arteries.

Event Description

It was reported to gore that on (b)(6) 2019, the patient was treated for a type a dissection with a gore® tag® thoracic endoprosthesis.A 13mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface was to be implanted for debranching in the left subclavian artery via a terumo 0.035 inch 260 cm soft guide wire.The endoprosthesis was deployed without the aid of fluoroscopy.Imaging revealed the device had been implanted 2 cm deeper into the subclavian artery than intended, and the vertebral artery was covered by the viabahn device.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• 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: vickie lang ; 9285263030
• MDR Report Key: 8618667
• MDR Text Key: 145350461
• Report Number: 2017233-2019-00357
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

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: 05/15/2021
• Device Catalogue Number: VBH130502W
• Device Lot Number: 18356212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• 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): Life Threatening
• Patient Age: 51 YR
• Patient Weight: 95