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

Device Problems Disconnection (1171); Malposition of Device (2616)

Patient Problems Aneurysm (1708); Hemorrhage/Bleeding (1888)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the lot number remains unknown.Therefore also the udi # remains unknown.The device remains implanted, so no engineering evaluation could be performed.As a second gore® viabahn® endoprosthesis was involved in the reported incident gore is submitting a report for each device reported.

Event Description

On (b)(6) 2017, a disconnection was diagnosed between the two gore® viabahn® endoprostheses.It was stated that the disconnection was based on an inaccurate positioning of the two devices and caused an endoleak type iii with aneurysm enlargement.To repair the disconnection a plc121200 contralateral leg component was implanted on (b)(6) 2017.

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6525241
• MDR Text Key: 73786568
• Report Number: 2017233-2017-00231
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• 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
• 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
• Treatment: GORE® VIABAHN® ENDOPROSTHESIS (13MM X 10CM).
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 52