MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Catalog Number PAJ062502

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

Patient Problem Thrombosis (2100)

Event Date 03/12/2012

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.Limp salvage was reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the lot number remains unknown.The device remains implanted so no engineering evaluation could be conducted.Multiple attempts were made to get additional information regarding the event.No further information was provided.

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

(b)(4).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).

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 4479160
• MDR Text Key: 5334770
• Report Number: 2017233-2015-00051
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: PAJ062502
• Device Lot Number: 9719142
• 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: 12/15/2011
• 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