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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pseudoaneurysm (2605)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be performed as the lot number remains unknown.According to the gore® viabahn® endoprosthesis instructions for use, complications associated with the use of the gore® viabahn® endoprosthesis may include but are not limited to: access site infection and pseudoaneurysm.

Event Description

The following was reported to gore: on an unknown date, the patient underwent an endovascular repair for the left superficial femoral artery using gore® viabahn® endoprosthesis with heparin bioactive surface in another hospital.On (b)(6) 2018, the patient underwent a surgery to repair a puncture site infection with a pseudoaneurysm in the left common femoral artery.The pseudoaneurysm was surgically removed, and the common femoral artery was repaired by patch angioplasty.The endoprosthesis and bare metal stent (implant date unknown) in the left iliac artery were left as they were.After the surgery, the patient was transferred to another hospital.

• 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: saori kawai ; 9285263030
• MDR Report Key: 7463652
• MDR Text Key: 106587390
• Report Number: 2017233-2018-00238
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/29/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention