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

Catalog Number PAC091002

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).The device remains implanted, so no engineering evaluation could be performed.

Event Description

The patient presented with an aneurysm in the popliteal artery which was treated with two gore® viabahn® endoprostheses on (b)(6) 2017.Successful deployment of the gore® viabahn® endoprosthesis and an aneurysm exclusion was reported.During the color flow duplex ultrasound, performed on (b)(6) 2017, a complete thrombosis of the left superficial femoral artery and left popliteal without any critical ischemia symptoms and without any trophic disorder of left foot was diagnosed.It was stated that the patient received drug therapy in order to treat the occlusion.

• 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: 6724127
• MDR Text Key: 80380490
• Report Number: 2017233-2017-00356
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: PAC091002
• Device Lot Number: 15748535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2016
• 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: 86 YR