MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2015, the patient was implanted with a gore® excluder® aaa endoprostheses and a gore® viabahn® endoprosthesis (unk lot number) to treat an abdominal aortic aneurysm and a right common iliac aneurysm.The doctor created an iliac branch endoprosthesis (ibe) using the gore® excluder® aaa endoprosthesis and the gore® viabahn® endoprosthesis.The gore® viabahn® endoprosthesis extended into the right common iliac artery.Images revealed a type iii endoleak between the gore® viabahn® endoprosthesis and the gore® excluder® aaa endoprosthesis with aneurysm enlargement.Re-intervention occurred (b)(6) 2017 to exclude the type iii endoleak.The patient tolerated the procedure.

Manufacturer Narrative

Additional manufacturer narrative: medwatch #2017233-2017-00485 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch will be retracted.Type of reportable event - (other).

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 6880151
• MDR Text Key: 86780062
• Report Number: 2017233-2017-00485
• Device Sequence Number: 1
• Product Code: NIP
• 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: 10/30/2017

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: 09/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2017
• 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
• Patient Age: 66 YR
• Patient Weight: 104