MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis (2100)

Event Date 01/30/2013

Event Type  Injury  

Manufacturer Narrative

The endoprosthesis remains implanted in the patient.As the device was not returned and the lot number remains unknown, no investigation could have been performed and therefore no results have been obtained.Review and analysis of all available information fails to indicate a potential root cause of the incident as reported within the reviewed literature article.

Event Description

The following abstract was reviewed: "multiple complications after endoprosthetic treatment of a popliteal aneurysm" peter lorenz et al.European journal of vascular medicine, volume 47, issue supplement 99, september 05, 2018 47.Jahrestagung deutsche gesellschaft für angiologie ¿ gesellschaft für gefässmedizin e.V.A (b)(6) year-old male patient presented with a popliteal aneurysm (2.2 cm) in the left leg with was treated endovascular with a viabahn endoprothesis in 2013.One month after the treatment, an acute occlusion of the prothesis as well as distal arteries occured.A recanalisation could be accomplished by an arterial local lytic therapy.

Manufacturer Narrative

As an addendum the literature related to this report is attached.(b)(4).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8938647
• MDR Text Key: 156602018
• Report Number: 2017233-2019-00752
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR