MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Device Problems Partial Blockage (1065); Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed 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

Literature article, 'fenstrated aortic endograft branching with gore vbx poses failure risk from delayed-onset branch kinking' (jeniann yi, m.D.& david kuwayama, m.D.; division of vascular surgery and endovascular therapy, department of surgery, university of colorado denver; j vasc.Surg cases and innovation techniques 2019;5:18-21) was reviewed.The article describes a case of near-occlusion of a gore® viabahn® vbx balloon expandable endoprosthesis celiac branch due to narrowing of this interspace identified at postoperative month 3.The article reported that the kinked/near occluded gore® viabahn® vbx balloon expandable endoprosthesis required a second procedure to reline the vbx using two atrium icase 7x22mm stents.

Manufacturer Narrative

Additional manufacturer narrative: a4 - patient weight, a5a - ethnicity, a5b - race, b7 - relevant medical history, d11 - concomitant medical devices & dates, g5 - combination product.Corrected data: b3 - event date.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8316275
• MDR Text Key: 135399151
• Report Number: 2017233-2019-00068
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODIFICATION ENDOGRAFT + ICAST STENTS - SAME DATE
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 77