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

Device Problem Insufficient Information (3190)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be performed as device item/lot numbers were not available.The images and device were no available, the imaging evaluation and engineering evaluation could not be performed.

Event Description

The following publication was reviewed: "use of the octopus technique for endovascular treatment of complex aortic lesions" received through "j vasc interv radiol 2019; 30:495¿502".The authors: ming-yi hsu, md, ta-wei su, md, i-hao su, md, kuo-sheng liu, md, phd, sung-yu chu, md, chien-ming chen, md, sheng-yueh yu, md, and po-jen ko, md.Material and methods: to evaluate feasibility and effectiveness using the octopus endograft technique to treat complex aortic aneurysms (caas).Endovascular repair of caas, including thoracoabdominal aneurysms (taaas) and dissections involving major side branches, was performed at a single center from june 2014 to june 2017.Patients included 9 men and 2 women (mean age, 60.5 y; range, 40¿89 y) were included.The octopus technique was applied using standard aortic grafts with branch stent grafts to preserve the renovisceral arteries.Results: aortic pathologies comprised 3 mycotic aneurysms, 2 chronic dissections with acute rupture, 1 progressively enlarging chronic type b dissection, 1 acutely ruptured taaa, and 4 unruptured taaas.Mean procedural and fluoroscopic times were 562 min(range, 324¿840 min) and 183 min (range, 73¿338 min), respectively.Three patients died within 1 month.Mean duration of follow-up was 26.3 months (range, 8¿42 months) for remaining patients.Technical success rate of target vessel stent placement was 89.7% (35/39).Major complication rate was 45.5% (5/11), including 3 deaths, 1 permanent paraplegia, and 1 temporary paraplegia that resolved in 2 months.All 3 mycotic aneurysms with mean duration of follow-up of 29 months (range, 8¿42 months) were excluded successfully without endoleak.Conclusions: the octopus technique is feasible for treatment of caas requiring urgent management or with difficult anatomy without the use of available custom-made or off-the-shelf branched devices.The procedure carries substantial morbidity and mortality and requires further investigation for its long-term durability.The results stated three 8-mm gore® viabahn® endoprosthesis were placed together side-by-side inside the short limb of the main body to revascularize major branch vessels.Another gore® viabahn® endoprosthesis were (7- or 8-mm) was placed inside the ipsilateral limb as a distal sandwiched graft to a fourth branch vessel when necessary.Branch vessel occlusion occurred in 2 patients during the follow-up period.One patient had a right renal stent occlusion 1 year after the procedure, with only a focal renal infarct and without functional impairment owing to preservation of the accessory right ra from the lower abdominal aorta.The other patient had bilateral stent occlusion at the 3-year follow-up with acute renal failure; this patient received thrombolysis with urokinase, but in vain.However, collateral flow into the renal arteries with opacification of the bilateral renal parenchyma was present, and renal function recovered to the normal range within a few weeks.The primary stent patency rate was 89.3% (25/28).No stent migration or disconnection was observed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8986805
• MDR Text Key: 161216917
• Report Number: 2017233-2019-00841
• 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: 09/23/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR