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

Device Problem Insufficient Information (3190)

Patient Problem Aneurysm (1708)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

The author was contacted and further details were requested like event date, serial no., implant-date and possible root causes.Other code: as the device remains implanted, a further investigation of the device cannot be performed.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

Within the article ¿in situ fenestration of a dislocated bridging stent graft after multibranched endografting of a thoraco-abdominal aortic aneurysm¿ from the odosios bisdas published in the european journal of vascular endovascular surgery on june 4, 2020, (volume 60, issue 2, august 2020, page 312) the following was indicated: introduction: branched endovascular repair (bevar) is well established in the treatment of thoraco-abdominal aortic aneurysms (taaa).Despite high technical success rates, the literature reports considerable reintervention rates associated with the bridging stent grafts (brsg).One of the most challenging complications is brsg migration from the target vessel (type ic endoleak according to newer classification).An endovascular technique to address seal failure due to brsg migration that can be applied to any dislocated brsg is demonstrated.Technique: a (b)(6) year old woman underwent bevar for type iii taaa.Predischarge computed tomography angiography demonstrated a type ic endoleak at the left renal artery.The brsg, namely a gore® viabahn® vbx balloon expandable endoprosthesis (w.L.Gore, tempe, az, usa) had migrated and was lodged between the aortic wall and main body in a descending position.A 10 fr fustar steerable introducer (lifetech scientific, shenzhen, china) with a 50 mm deflectable tip, several balloons, and catheters were unsuccessfully employed to dislodge the brsg and reposition it in the left renal artery.Using an outback re-entry device (cordis, bridgewater township, nj, usa) over a 0.014¿ wire through the subclavian artery, an in situ fenestration was successfully created through the brsg with direct cannulation of the renal artery.Using balloon catheters after exchange to a rosen wire through a trailblazer support catheter (medtronic, minneapolis, mn, usa), the diameter of the fenestration was increased gradually to four mm, and a 7 mm gore® viabahn® vbx balloon expandable endoprosthesis was deployed into the renal artery.Completion angiography showed a satisfactory result despite the hourglass shape of the new brsg passing through the struts of the old one.One year follow up confirmed the patency and positioning of the second brsg.Conclusion: for failure to reposition a migrated and lodged brsg after bevar, creating an in situ fenestration on the wall of the migrated brsg by using a re-entry device and deploying a new brsg into the respective vessel is a viable bailout technique.

Manufacturer Narrative

H6: component code 515 added.H6: investigation conclusion and investigation findings updated.

Manufacturer Narrative

Attached literature article.

• 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: 11684503
• MDR Text Key: 246755088
• Report Number: 2017233-2021-01870
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: P160021
• 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,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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: 04/08/2022
• 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
• Treatment: OUTBACK RE-ENTRY DEVICE (CORDIS, BRIDGEWATER TOWNS
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female