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

Catalog Number JHJR050202J

Device Problem Difficult to Advance (2920)

Patient Problem Occlusion (1984)

Event Date 03/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

In a review of published literature, the following findings were noted: yasuhiro fujiwara et al., ¿a case of bleeding of cha pseudoaneurysm developed after pd which was treated by a viabahn¿ in ivr: interventional radiology, volume 32, number 4, page 331 (january, 2018).This patient was male and was in his eighties.The patient underwent a pancreaticoduodenectomy (pd) and a segmentectomy of s4 (medial segment) of the liver as the patient had a duodenal cancer with liver metastasis (s4).Postoperative day 6, biliary fistula developed and a percutaneous transhepatic biliary drainage (ptbd) was performed.Pancreatic fistula was also suspected.Postoperative day 17, bleeding from a drain tube was observed.Angiography showed bleeding from a pseudoaneurysm of the common hepatic artery (cha).On (b)(6) 2017, it was elected to use a gore® viabahn® endoprosthesis with heparin bioactive surface for hemostasis.Angiography also showed a stenosis of the proper hepatic artery (pha).As it was impossible to deliver the endoprosthesis to the stenosis of the pha, the endoprosthesis was implanted at the pseudoaneurysm of the cha and hemostasis was achieved.However, the endoprosthesis was occluded after the implantation.It was reported that spasm might have caused the occlusion, but definitive cause was unknown.As blood flow from the superficial femoral artery into the liver was confirmed, no treatment was performed for the occlusion.The procedure was concluded.On (b)(6) 2017 (6th day after the procedure), liver abscess developed, and drainage was performed.No further information was available.

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lots met all pre-release specifications.

Manufacturer Narrative

(b)(4).

Event Description

As blood flow from the superior mesenteric artery into the liver was confirmed, no treatment was performed for the occlusion.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7536147
• MDR Text Key: 108977409
• Report Number: 2017233-2018-00300
• 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,litera
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2018

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
• Device Expiration Date: 11/23/2018
• Device Catalogue Number: JHJR050202J
• Device Lot Number: 14857740
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/20/2018; 06/20/2018; 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other