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

Catalog Number PAJR061002B

Device Problem Complete Blockage (1094)

Patient Problem Stenosis (2263)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

A separate report, 2017233-2020-00185 is being sent to address patient no.1.

Event Description

The following information was reported to gore: in an article titled technical considerations and clinical outcomes in the endovascular management of celiac arterial aneurysms it states two patients who underwent treatment of celiac artery aneurysms who were treated with either gore® viabahn® endoprosthesis with propaten bioactive surface or gore® viabahn® vbx balloon expandable endoprosthesis had device related post-procedural complications: patient no.2 was treated with a gore® viabahn® endoprosthesis and developed 80%¿90% isr at 10-month follow-up ct angiogram.After angioplasty and stenting of this stenosis, ct angiogram performed 18 months after the procedure demonstrated complete stent graft thrombosis with adequate collateral flow established through a patent gda and distal sa.The patient was completely asymptomatic with no radiographic evidence of end-organ ischemia or biochemical abnormalities.

Event Description

In an article titled technical considerations and clinical outcomes in the endovascular management of celiac arterial aneurysms it states some patients who underwent treatment of celiac artery aneurysms who were treated with either gore® viabahn® endoprosthesis with propaten bioactive surface or gore® viabahn® vbx balloon expandable endoprosthesis had device related post-procedural complications.Patient no.2 was treated with a gore® viabahn® endoprosthesis and developed 80%¿90% isr at 10-month follow-up ct angiogram.After angioplasty and stenting of this stenosis, ct angiogram performed 18 months after the procedure demonstrated complete stent graft thrombosis with adequate collateral flow established through a patent gda and distal sa.The patient was completely asymptomatic with no radiographic evidence of end-organ ischemia or biochemical abnormalities.

Manufacturer Narrative

B.5.Updated.Patient#: 4 is being reported under mfr report#: 2017233-2020-00249.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9832899
• MDR Text Key: 191075025
• Report Number: 2017233-2020-00186
• 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
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

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 Catalogue Number: PAJR061002B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 43 YR