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

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 06/30/2018

Event Type  Injury  

Manufacturer Narrative

As the devices remain implanted, an investigation on the devices cannot be performed.No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The mean patient age is 70 years and the gender male as stated in the article.The author was contacted and further details requested, such as lot- / serial no., implant date, patient data and possible root cause.The date of event is unknown.Therefore as date of event was chosen when the literature article was published, here december 29, 2020.Concomitant medical products: zenith stent-graft platform (cook medical) which generally contained four cuffs.Two types of side-branched devices were used: a custom made-device and an off-the-shelf side-branched device (t-branchvr , cook medical).Advanta v12-icast (getinge maquet, rastatt, germany) smartflex (cardinal health, dublin, oh, usa).The following publication was reviewed: ¿aortic endograft and bridging stent-graft remodeling after branched endovascular aortic repair¿ (stefano fazzini, et.Al, vascular 2021, vol.29(6) 808¿816, published online december 29, 2020).This article involves multiple devices from the same manufacturer.Another report with the manufacturer report number 2017233-2022-02853 was submitted.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following publication was reviewed: ¿aortic endograft and bridging stent-graft remodeling after branched endovascular aortic repair¿ (stefano fazzini, et.Al, vascular 2021, vol.29(6) 808¿816, published online december 29, 2020).This single center study analyzes patients treated with branched endovascular aortic repair (bevar) from january 2017 to june 2018 for thoracoabdominal aortic aneurysms (taaa) at a single institution.Computed tomoangiographies of 43 patients (43 aortic main body mated with 171 bridging stent-grafts) were analyzed before and after branched endovascular repair as well as after a follow-up of 12 months.All thoraco-abdominal branched endografts (amb) were based on the zenith stent-graft platform (cook medical) and generally contained four cuffs.Two types of side-branched devices were used: a custom made-device and an off-the-shelf side-branched device (t-branchvr , cook medical).Depending on the clinical conditions, custom-made devices were used for elective cases, whereas t-branch was mainly used for urgent indications as previously described.4 all ambs were manufactured with caudally directed cuffs.Thoracic aortic endografts were used for proximal grafting in case of type ii and iii taaa.The thoraco-abdominal side-branched devices were connected with the target vessels (tvs) using balloon expandable covered stents as main bridging stent-graft (bsg), distally extended with self-expanding bare stents in case of angulated anatomy or to increase the distal landing zone maintaining the patency of side-branches.The most used covered stents were advanta v12-icast (getinge maquet, rastatt, germany) mated with gore® viabahn® endoprostheses and the gore viabahn® vbx balloon expandable endoprosthesis.The most used self-expanding bare metal stent was the smartflex (cardinal health, dublin, oh, usa) as distal bsg mainly for visceral arteries.The article mentions 16 cases of bsg instability.Bsg instability was defined as any bsg-related reintervention or bsg occlusion without reintervention.The bsg reintervention and occlusion rate were 8.2% and 1.1%.Two cases with multiple bsg instability were observed (triple distal edge stenosis; triple stenosis and one occlusion).14 bsgs were treated with secondary procedures, bar the two bsg asymptomatic occlusions (one celiac trunk and one renal artery).7 type ic endoleaks were detected at postoperative cta and subsequently treated with distal relining.It is mentioned that bsg instability occurred in four advanta/gore® viabahn® endoprostheses, but not stated which type of instability.The article does not state which type of instability is related to the devices.It is mentioned that bsg instability occurred in eight gore viabahn® vbx balloon expandable endoprosthesis, but not stated which type of instability.

Manufacturer Narrative

Product history review: a review of the manufacturing records for the devices could not be conducted because the serial/lot numbers remain unknown.As the devices remain implanted, an investigation on the devices cannot be performed.Multiple attempts were made to obtain additional information about these events, such as lot- / serial no., implant date, patient data and possible root cause.No additional information was provided.With the information provided to gore, the cause of the reported event could not be established.

• 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: 14053512
• MDR Text Key: 288888229
• Report Number: 2017233-2022-02854
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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: 09/28/2022
• 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: 70 YR
• Patient Sex: Male