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

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/22/2014

Event Type  Injury  

Event Description

The retrospective article, ¿endovascular treatment of popliteal artery aneurysm.Early and midterm results¿ (rev.Col.Bras.Cir.2015; 42(1): 037-041) was reviewed.Over a six year period, ending in 2012, the gore viabahn® endoprosthesis was implanted in 12 cases for endovascular repair of popliteal artery aneurysms.It was reported in the article that one patient developed acute arterial obstruction on the first day after surgery and was treated successfully with thrombolysis.

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.Date when the article was accepted ((b)(6) 2014) has been used as the date the incident occurred.

Manufacturer Narrative

(b)(4).

• 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4954858
• MDR Text Key: 6253900
• Report Number: 2017233-2015-00483
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K013648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• 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?: No
• 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: 72 YR