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

Catalog Number JHJR071502J

Device Problem Complete Blockage (1094)

Patient Problems Aneurysm (1708); Occlusion (1984)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.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.All information has been placed on file for use in tracking and trending.

Event Description

The following was reported to gore; on (b)(6) 2019, the patient underwent endovascular repair.The gore® viabahn® endoprosthesis was implanted in the celiac artery as a chimney device.The procedure was completed without any complications.The same day (6 hours later), the patient complained of abdominal pain.It was reported that the acidosis level was increased.Ct imaging showed an occlusion of the gore® viabahn® endoprosthesis in the celiac artery.Thrombus aspiration and ballooning were performed to treat the occlusion.Urokinase was then administrated, and the abdominal pain was resolved.Heparin and dual antiplatelet therapy (dapt) were also administrated.The acidosis level returned to a normal level.The patient tolerated the procedure.

Manufacturer Narrative

Corrected data: b5 describe event or problem.

Event Description

The following was reported to gore; on (b)(6), 2019, the patient underwent endovascular repair.The gore® viabahn® endoprosthesis was implanted in the celiac artery as a chimney device.The procedure was completed without any complications.The same day (6 hours later), the patient complained of abdominal pain.It was reported that the acidosis level was increased.Ct imaging showed an occlusion of the gore® viabahn® endoprosthesis and slightly compressed in the celiac artery.Thrombus aspiration and ballooning were performed to treat the occlusion.Urokinase was then administrated, and the abdominal pain was resolved.Heparin and dual antiplatelet therapy (dapt) were also administrated.The acidosis level returned to a normal level.The patient tolerated the procedure.

Manufacturer Narrative

Corrected data: h6 patient code 1.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8932948
• MDR Text Key: 156300971
• Report Number: 2017233-2019-00726
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2019

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
• Device Expiration Date: 11/18/2019
• Device Catalogue Number: JHJR071502J
• Device Lot Number: 16006074
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/28/2019; 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR