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

Catalog Number VBC081002

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation of Vessels (2135)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Imaging evaluation results.Intended use / indications state, the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis 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.W.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa and the antecubital fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.

Event Description

It was reported to gore that a 8mm x 10cm gore® viabahn® endoprosthesis was to be implanted for treatment of the splenic artery aneurysm.Because of the excessively tortuous vessels, resistance was reportedly felt during device advancement.The splenic artery aneurysm was ruptured due to the excessive force used during attempts to get the viabahn device to treatment site.The constrained gore® viabahn® endoprosthesis was retracted out of the patient.Coiling was done to stop the bleeding and the patient was transferred to the icu for surgical intervention.The patient tolerated the procedure.

• 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: 8193428
• MDR Text Key: 131306321
• Report Number: 2017233-2018-00795
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132614608
• UDI-Public: 00733132614608
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Catalogue Number: VBC081002
• Device Lot Number: 18278635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2018
• 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): Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70