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

Catalog Number BXA115902E

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2020

Event Type  Injury  

Event Description

The following literature article was reviewed:¿ current opinions in open and endovascular treatment of major arterial injuries in pediatric patient¿ published by marco franchin et al.On 26 july 2023 in the journal of clinical medicine 2023, 12, 4906, pages 1-11.Pediatric major arterial vascular injuries may belong to the same principal categories as adults, but over the course of the last decades, they have been poorly documented.First, there is not a commonly accepted threshold to define a pediatric vascular injury, but according to most of the published literature, it should be defined as a vascular injury occurring in patients between 2 and 16 years of age.Second, the true incidence is still matter of debate, since most reported experiences primarily concerned upper and lower extremity injuries, while lesions of the supra-aortic trunks or of the torso (e.G., thorax and abdomen) were rarely included.Last, open surgery has been the mainstay of treatment, but no clear guidelines have been developed to recommend the best practice patterns in terms of strategy or repair as well as postoperative pharmacological regimen.This article included a report of three cases, as well as a summary of the available literature regarding the main aspects of dealing with pediatric arterial injuries based on the predominant series available from the published literature.In one case study, a 15-year-old female patient was referred to the emergency department after motorway low-speed trauma (motor vehicle driver against fixed obstacle).At arrival, the computed tomography-angiography showed a 10 mm, type 2, abdominal aortic tear with a focal surrounding intramural hematoma.The lesion was sealed using an endovascular repair using a balloon-expandable covered stent (gore® viabahn® vbx balloon expandable endoprosthesis).The deployment was uneventful.However, after the molding of the covered stent to optimize stent adaptation to the aortic size, the completion angiography unexpectedly showed the proximal migration of the covered stent at the level of the superior mesenteric artery.An open conversion was performed to explant the covered stent after it was gently mobilized infrarenal with the use of an angioplasty balloon.The direct exploration of the aorta confirmed the focal defect with no interruption of the aortic wall and the lesion was repaired using a xeno-pericardium patch angioplasty posteriorly reinforced with a teflon strip felt.No postoperative complications were observed and the patient was discharged home on postoperative day five on single antiplatelet therapy.At 36 months follow-up, the patient was alive and well with no disability; duplex-ultrasound confirmed the patency of the terminal aorta without prosthetic complication at the site of the aortic repair.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2/a3: the patients age is 15 years and the gender female, as stated in the article.B3: date of event was determined as date when literature article was published, here (b)(6) 2023.D6a/d6b: implant- and explant date is unknown.Further details were requested from the corresponding author such as serial no., implant- and explant dates, date of event, patient id's and weight, and possible root cause as well as if device is available for further investigation.Until now no further information was provided.Product history review: a review of the manufacturing records for the device could not be conducted because the serial/lot number was not provided yet.H3: other code: as the status of the device is unknown and it was not made available until now, a further investigation cannot be conducted.Cbas® 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.

Manufacturer Narrative

Further details were received from the physician and added and/or updated as follows: as the device is not available anymore, no further investigation of the device can be performed.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the device met pre-release specifications.Evaluation of received items: (a) clinical images of the case study were included in the literature article, and an imaging evaluation was performed by a clinical imaging specialist.Reviewed images are included in the imaging evaluation report attachment in smartsolve.The following was noted: ¿ unable to confirm the event as it is described.Images cannot be manipulated in anyway.¿ the images received could not be used to perform a full imaging evaluation as they do not meet dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the image provided for review.(b) a series of surgical images were presented in the literature article and attributed to the intraoperative findings of the case study patient.The images can be found on page 5 of 11 of the literature article attachment in smartsolve.The caption corresponding to the collection of images details surgical exposure of the aorta to remove a vbx device.The vbx device could not be independently identified from the images available for review due to magnification quality.Therefore, the images could not be assessed for product performance relative to the reported migration allegation.The reported stent-graft migration following successful deployment and molding of the endoprosthesis for wall apposition could not be independently confirmed with the items available for review.The literature article reports treatment of an aortic lesion arising from traumatic arterial injury of the abdominal aorta.The authors indicate there was accurate deployment and positioning of the stent-graft in the infrarenal aorta followed by proximal migration at the level of the superior mesenteric artery in the suprarenal aorta.Use of the vbx device for treatment of lesions in the aorta is an off-indication use of the device consistent with the migration event as reported and the subsequent removal of the device for alternative treatment.The ifu details the indications for use of the vbx device, including traumatic or iatrogenic vessel injuries in arteries located in the abdominal cavity and excluding the aorta.Therefore, the root cause of the device migration and surgical removal is consistent with off-label use as reported.The physician stated that he can confirm that the vbx-device was successfully expanded and that he guess that the adverse event is not attributable to the endoprothesis itself.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• 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: 17681741
• MDR Text Key: 322611288
• Report Number: 2017233-2023-04251
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2022
• Device Catalogue Number: BXA115902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• 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
• Treatment: ANGIOPLASTY BALLOON, XENO-PERICARDIUM PATCH ANGIOP
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 45 KG