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

Catalog Number PAJ061502

Device Problem Insufficient Information (3190)

Patient Problems Thrombosis (2100); Stenosis (2263); Claudication (2550)

Event Date 03/13/2012

Event Type  Injury  

Event Description

It was reported to gore that a patient presented with a claudication in the right leg with a stenosis/occlusion between the superficial femoral artery and the popliteal artery.On (b)(6) 2012, a gore® viabahn® endoprosthesis was implanted.On (b)(6) 2012, an acute thrombosis of the endoprosthesis was diagnosed and on (b)(6) 2012, a catheter thrombolysis was unsuccessfully performed.Limb salvage was reported.This incident was from a retrospective evaluation of patients (conducted by dr (b)(6)) who were treated with covered stents and bare-metal stents of occlusive disease of the femoropopliteal artery between 2009 and 2012.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.Gore received the information that three gore® viabahn® endoprostheses were implanted for this patient.Therefore gore is submitting a report for each lot reported (lot #9719142, lot #8563977, lot #8716339).

Manufacturer Narrative

Additional information: conclusion codes were added.

• 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 86001
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4772413
• MDR Text Key: 5777017
• Report Number: 2017233-2015-00288
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: PAJ061502
• Device Lot Number: 8716339
• 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: 02/16/2011
• 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: 59 YR