MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Vascular Dissection (3160)

Event Date 11/03/2022

Event Type  Injury  

Event Description

The following publishment was reviewed by gore: title: total arch replacement with extended branched stented anastomosis frozen elephant trunk repair for type a dissection improves operative outcome source: journal of thoracic and cardiovascular surgery techniques volume 17, number c p.1-9 objective: we compared the outcomes of extended branched stented anastomosis frozen elephant trunk repair (eb-safer) and conventional total arch replacement (ctar) in acute aortic dissection type a.Methods: between 2016 and 2021, 58 patients underwent emergency repair of type a aortic dissection with a patent false lumen using tar.Eb-safer was performed in 21 of 58 patients.For the procedure, the aortic arch was transected circumferentially distal to the brachiocephalic artery origin.Frozen elephant trunk was fenestrated by heating with a cautery, and the self-expandable stent graft was delivered into the branch vessels through the fenestration.The branch vessel graft (5.0 cm long gore® viabahn® endoprosthesis with heparin bioactive surface) was placed directly through the hole into the target vessel and deployed into the target vessel with approximately 15 mm extending into the aortic arch lumen.Results: of 58 cases, 21 and 37 were classified in the eb-safer and ctar groups, respectively.Six surgical deaths occurred: two (9%) in the eb-safer group and four (10 %) in the ctar group.In all cases, only one patient (2 %) in the ctar group had a branch artery¿related complication during the postoperative follow-up period.The 30-day operative mortality was 9.5 % (n = 2 of 21) in the eb-safer group and 10.8 % (n = 4 of 37) in the ctar group.Two patients presented with myocardial infarction of the left anterior descending artery and aortic root rupture in the eb-safer group, and 2 of the 4 patients presented with shock due to rupture and the other two presented with disseminated intravascular coagulation due to postoperative infection in the ctar group.Stent patency was found in all 21 cases in the eb-safer group.There was no occurrence of negative factors due to the use of self-expanding stent grafts.There was no junction endoleak (type 3), and the number of new-onset vessel dissections was low.One patient was additionally treated for type 1b endoleak of the subclavian artery.The additional treatment involved the use of a covered stent, and the endoleak disappeared.Consequently, there were no eb-safer¿induced neurological complications.Three patients (10%) had postoperative radiographic evidence of stroke: one patient (3%) in the eb-safer group and two patients (5%) in the ctar group.One patient in the eb-safer group in whom encephalopathy occurred immediately after surgery eventually recovered.The present study included eb-safer in 10 patients (47.7%) with dissection in the cervical branches.Among them, there was only one case of stroke complication in the acute phase.This may be due to the advantage of self-expanding stent grafts, which enlarge the lumen more distally.Conclusions: extended branched stented anastomosis frozen elephant trunk repair has shown comparable safety and efficacy to conventional total arch replacement and can be used for acute aortic dissection type a emergency repair.It optimizes true lumen perfusion and facilitates supra-aortic artery remodeling.

Manufacturer Narrative

C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code "other" was selected as the medical device remains implanted.Return not possible.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H.6.Investigation conclusions code d12: according to the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use: possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with heparin bioactive surface or in any endovascular procedure and require intervention include, but are not limited to endoleak and/or endotension.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17037826
• MDR Text Key: 316393695
• Report Number: 2017233-2023-03972
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR