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

Device Problems Off-Label Use (1494); Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); Renal Impairment (4499)

Event Date 06/22/2023

Event Type  Injury  

Event Description

The following literature article was reviewed: ¿results of the chimney technique in a community hospital¿ published by denise m.D.Özdemir-van brunschot et al.On june 22, 2023, in the journal of vascular and endovascular surgery, 2024;58(1):20-28.This is a retrospective study single center study of patients undergoing chimney technique, fenestrated or branched endovascular aortic repair (chevar) in patients with a juxtarenal, suprarenal or type iv thoraco-abdominal aneurysm between january 1, 2011 through december 31, 2020 in a community hospital.There were 38 patients included in the study, mostly male (94.7%) with a mean age of 72.2.Excluded patients included revisions of existing evar and patients with a para-anastomotic aneurysm.Four patients presented with a symptomatic aneurysm and 1 patient with a contained ruptured aneurysm.Most patients had a juxtarenal aneurysm (68.4%).A total of 59 chimney grafts were deployed: 29 in the left (49.2%), 25 in the right renal artery (42.4%) and 5 in the superior mesenteric artery (8.5%).No chimney grafts were deployed in the coeliac artery.In 20 patients a single chimney graft (52.6%), in 15 patients 2 chimney graft (39.5%), and in 3 patients 3 chimney graft (7.9%) were deployed.Technical success was 100%.13 lifestream stents (22.0%), 33 viabahn stents (55.9%), 7 begraft stents (11.9%) and 5 advanta stents (8.5%) were used.In 1 patient the manufacturer of the stent graft was not mentioned (1.7%).In the early postoperative period, there were 4 cases of renal chimney graft occlusion.Thrombosis was attempted in 3 patients but could not regain patency of the chimney grafts.In 1 patient an iliac renal bypass of the chimney grafts and the other 3, renal function improved, and not further therapy was performed.Gutter endoleak: 4 patients.One patient was successfully treated with coiling of the aneurysm sac.Two patients were successfully treated with extension of the chimney grafts and cuff implantation.One patient required no treatment.In the follow-up period [median follow up was 26.6 months] 5 additional patients presented with a chimney graft occlusion.In all patients a renal infarction was seen on ct-angiography.Attempts to salvage the chimney graft was made in 3 patients but catheterization failed in all patients.Renal function stabilized in all 3 patients and dialysis was not necessary.Conclusions in this retrospective study, results from 38 patients treated with the chimney technique are presented.Chimney graft occlusion rate was 15.3% at the end of follow-up.The majority of the occluded stents were self-expandable stents, thereby underscoring the necessity of appropriate choice of stent graft.Also, it should be avoided that the proximal part of the chimney graft ends at the level of the suprarenal crown.Chevar should be used with caution in elective patients with suprarenal or juxtarenal aneurysms.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the case number.A2 / a3: the patients mean age is 72 years and the gender male as stated in the article.B3: date of event was determined as date when literature article was published online, here june 22, 2023.H3 other code: as the device availability remains unknown, no further investigation can be performed.Product history review: a review of the manufacturing records for the devices could not be conducted because the serial/lot numbers remain unknown.Further details were requested from the corresponding author such as serial no's., implant date, date of event, patient id's, age, gender and weight, medical history of patient and possible root cause.Until now no further information was provided.Further investigation is being conducted and will be included in the final report.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Özdemir-van brunschot dmd, tevs m, holzhey d.Results of the chimney technique in a community hospital.Vascular and endovascular surgery.2024;58(1):20-28.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

Neither clinical images enabling direct assessment of product performance, nor the devices were returned for investigation.The corresponding author was contacted to ask, if the post-operative complications are related to our vsx-devices and/or if she can confirm that our gore devices have not malfunctioned and the complication and/or adverse events observed are not attributable to our vsx-devices.Furthermore details like event dates, serial no.'s, implant-dates, patient details, possible root causes and if the devices are available for investigation were requested.No further information was provided.With the available information, we are unable to determine the cause of this incident and assign a root cause.C20 was selected because no device investigations were able to be performed as no further information was able to be obtained from the authors and we did not receive the devices back for evaluation.D1103 was selected as using the viabahn device as a chimney is off-label use.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: occlusion (thrombosis and/or stenosis) of endoprosthesis or vessel.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18503724
• MDR Text Key: 332786996
• Report Number: 2017233-2024-04545
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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: 12/13/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/11/2024
• 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
• Treatment: ENDURANT STENT GRAFT SYSTEM(MEDTRONIC, SANTA ROSA)
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male