MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Device Problems Fracture (1260); Material Split, Cut or Torn (4008)

Event Date 10/23/2022

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number_ a2/a3/a4: patient age, gender and weight were not stated in the article.B3: date of event was determined as date when literature article was accepted, here (b)(6) 2022.D6a/d6b: the implant- and explant dates were requested from the author, but not provided yet.H3: as the status of the device is unknown, no investigation of the devices can be performed.H3: review of the manufacturing records could not be performed as a valid lot number was not provided.The corresponding author was contacted and further details requested, such as lot- / serial no., implant- and explant dates, patient data and possible root cause, but were not provided yet.The following literature article was reviewed: ¿analysis of predisposing factors for type iii endoleaks from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms¿, published by stefano gennai et al.On october 23, 2022, in the journal of vascular surgery, volume 77, issue 3, 2023, pages 677-684.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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.

Event Description

The following literature article was reviewed: ¿analysis of predisposing factors for type iii endoleaks from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms¿, published by stefano gennai et al.On october 23, 2022, in the journal of vascular surgery, volume 77, issue 3, 2023, pages 677-684.The article indicated the following: according to a report published by stefano gennai, [2023], use of the gore® viabahn® vbx balloon expandable endoprosthesis was evaluated in patients undergoing branched endovascular repair.295 target visceral vessels in 91 patients were considered suitable for cannulation.In the total 295 visceral vessels, 33 visceral vessels were treated with gore® viabahn® vbx balloon expandable endoprosthesis.Description: this retrospective study targeted analysis of predisposing factors for type iii endoleaks from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms.Mid-term durability of branches has already been established, and bf-branched and fenestrated endovascular repair has shown comparable results with open repair in the treatment of thoracoabdominal aortic aneurysms (taaas).Nevertheless, target vessel instability remains the most frequent adverse event after complex endovascular aortic repair.Type iii endoleaks from directional branches have been reported with a low incidence, but risk factors for this complication have not been investigated yet.This was a dual-center observational retrospective cohort study.Data were collected prospectively for each patient treated with branched endovascular repair between april 2008 and december 2019.The primary outcome was to assess potential risk factors for branch disconnection and fracture.A logistic regression analysis was performed, including preoperative and postoperative measurements as well as intraoperative details.A cox regression hazard analysis was performed to evaluate the influence of preoperative aneurysm diameter and target vessel angulation on the outcome during follow-up.Results: two hundred ninety-five target visceral vessels (tvvs) in 91 patients were considered suitable for cannulation.Technical success was 96.9% (286/295 tvvs).The median follow-up was 32.5 months.Twelve type iii endoleaks from directional branches were detected (5 bridging stent graft fractures and 7 disconnections).Five type iii endoleaks involved the celiac trunk (one fracture and four disconnections), five the superior mesenteric artery (four fractures and one disconnection), and two the renal arteries (both disconnections).The median time to type iii endoleak was 22.2 months.Preoperative taaa diameter, preoperative tvv angulation, the use of a begraft stent graft as bridging stent graft, and different stent types on the same vessel were associated with type iii endoleak at univariable analysis.Using a begraft stent graft was the only significant factor predisposing to type iii endoleak at multiple logistic regression.The only complication outlined within the literature specific to the gore® viabahn® vbx balloon expandable endoprosthesis device is noted as follows: bsg [bridging stent graft] fracture leading to cumulative type iii el [endoleaks] - 3.0% 1/33 [vessels].

Manufacturer Narrative

H6 evaluation codes investigation findings c20 was selected because no device investigations were able to be performed as no further information was able to be obtained from the authors (despite multiple attempts) and we did not receive the devices back for evaluation.Multiple attempts were made to obtain additional information from the author and further details were requested, like event date, serial no., implant date, patient data and possible root causes, but the requests remained unanswered.The serial numbers remain unknown, therefore a review of the manufacturing records could not be performed.Neither images enabling direct assessment of product performance nor the product itself were returned for evaluation.With no additional information provided, gore is unable to perform further investigations of this complaint and the cause of the reported event could not be established.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: adverse events: possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with propaten bioactive surface or in any endovascular procedure and require intervention include, but are not limited to: device fracture, endoleak and/or endotension the involved gore device is a gore® viabahn® endoprosthesis with propaten bioactive surface instead of a gore® viabahn® vbx balloon expandable endoprosthesis.B6 correction: the only complication outlined within the literature specific to the gore® viabahn® endoprosthesis with propaten bioactive surface device is noted as follows: bsg [bridging stent graft] fracture leading to cumulative type iii el [endoleaks] - 3.0% 1/33 [vessels] d1/d2a/d2b corrected.G3 / g4: pma/510(k)number: p130006 corrected.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17010598
• MDR Text Key: 316093731
• Report Number: 2017233-2023-03963
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/23/2023
• 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