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

Device Problem Migration (4003)

Patient Problems Aneurysm (1708); Blood Loss (2597)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.

Event Description

The following publication was reviewed: 'six cases of stent graft placement for treating common hepatic artery bleeding/aneurysm'; the 48th annual meeting of the japanese society of interventional radiology; poster session 33; covered stent 2 in june 1, 2019.Six patients received the gore® viabahn® endoprosthesis with heparin bioactive surface (sg) in the common hepatic artery (cha) to treat bleeding/aneurysms.Four of the patients had no sg occlusion during the follow-up period (up to 14 months).One patient has not been able to be followed up for sg patency because of iodine contrast agent allergy.One patient had sg occlusion five months after the procedure and the sg disappeared (possibly migrated) after 10 months.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• 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: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9181326
• MDR Text Key: 163553097
• Report Number: 2017233-2019-01012
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: 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