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

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records could not be performed as the lot number remains unknown.According to the gore® viabahn® endoprosthesis instructions for use, complications associated with the use of the gore® viabahn® endoprosthesis may include but are not limited to: occlusion.

Event Description

In a review of published literature, the following findings were noted: hidemasa saito et al., ¿early experiences of stent graft (viabahn) treatment for vessel injury¿ in the journal of japanese college of angiology, volume 57 supplement, page s138 (published in october, 2017).Between january of 2017 and may of 2017, 5 patients with 6 lesions (average age: 73.0 plus or minus 6.6, male: 4 and female: 1) were treated using a gore® viabahn® endoprosthesis for vessel injury.1 patient had 2 injuries and both were repaired by the endoprosthesis.The affected vessels were common hepatic artery, proper hepatic artery, gastroduodenal artery, splenic artery, right renal artery and right superficial femoral artery.Initial procedure was technically success and hemostasis was achieved in the all cases.It was reported that 7 days after the initial procedure, angiography confirmed that 2 endoprostheses implanted in 1 patient were occluded.Distal organ perfusion was preserved by collateral circulation.No further issue was reported.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: saori kawai ; 9285263030
• MDR Report Key: 7250396
• MDR Text Key: 99300486
• Report Number: 2017233-2018-00084
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2018
• 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): Other