MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE HEMOBAHN® ENDOPROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problems Ischemia (1942); Thrombosis (2100)

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.The article reported that over a six year period, ending in 2012, the gore hemobahn® endoprosthesis was implanted in 1 case for endovascular repair of popliteal artery aneurysms.It was reported the patient showed thrombosis of the hemobahn and ischemia of moderate to severe intensity on day 30 postoperatively, undergoing a successful femoropopliteal bridge with a polytetrafluoroethylene prosthesis.

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.

Manufacturer Narrative

The gore® hemobahn® endoprosthesis was never approved for distribution in the us.Therefore, this event is not reportable.This supplemental serves as a retraction of mewdatch 2017233-2015-00478.

• Brand Name: GORE HEMOBAHN® ENDOPROSTHESIS
• 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: 4953502
• MDR Text Key: 6038904
• Report Number: 2017233-2015-00478
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/30/2015

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?: Yes
• 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