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

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Activation, Positioning or Separation Problem (2906)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Article - case report: multiple chimney endografts (chevar) for ruptured pararenal aortic aneurysm.Jay jennings,1 ld sheahan,2 cc gloss,2 todd r vogel,3 and jonathan bath,3 columbia, mo.Ann vasc surg 2021; 75: 531.E531¿531.E6.Published online 6 april 2021.Date of online publication was used as date of event.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Review of device manufacturing record history could not be conducted as device(s) lot/serial number was requested but not made available.Article indicates an additional device was implanted during intervention to address the endoleak issue.Device remains implanted; therefore, direct product analysis was not possible.Event details and patient details were requested from author/complainant.As of today, no information has been provided.Patient identifier, dob, weight, co-morbidities, and medications have not been provided.

Event Description

Case report: multiple chimney endografts (chevar) for ruptured pararenal aortic aneurysm.Jay jennings,1 ld sheahan,2 cc gloss,2 todd r vogel,3 and jonathan bath,3 columbia, mo.Ann vasc surg 2021; 75: 531.E531¿531.E6.Published online 6 april 2021.A (b)(6) male patient presented with abdominal pain and hypotension in an emergency case.Computed tomography angiography (ct-a) revealed a ruptured pararenal aaa.The patient was a poor risk for an open paravisceral aneurysm repair given his home oxygen requirement and known reduced ejection fraction.The aneurysm was close to the superior mesenteric artery (sma) and renal arteries.Consequently, the seal zone was set to just above the celiac artery.Preoperative imaging showed the celiac artery origin was diminutive with a patent gastroduodenal artery (gda) influencing the decision to cover the celiac artery without revascularization.From left femoral artery, ultrasound-guided access was obtained and a 14fr x 45cm sheath was placed.Left axillary exposure below the clavicle was done to facilitate the placement of two 7fr x 90 cm sheaths above the target visceral arteries.Bilateral femoral access was then secured utilizing a preclose technique with placement of a 16 fr x 28 cm sheath.Selective cannulation of the sma and right renal artery from the axillary exposure was completed and over 260 cm cook rosen wires, sheath access was maintained 2 cm into the target vessels.A 36mm medtronic e2s bifurcated aortic graft was deployed just inferior to the left renal artery.The left renal artery was cannulated with a 7fr x 45 cm sheath over a cook rosen wire.Sheath access was obtained to the sma and right renal artery in an antegrade (chimney) configuration and the left renal artery in a retrograde (periscope) configuration.Through right femoral access, a 46 × 93 mm navion thoracic endograft (medtronic) was then placed 1cm above the infrarenal endograft flow divider.This provided 4 cm of overlap between the infrarenal and the bridging thoracic endograft.Gore® viabahn® vbx balloon expandable endoprosthesis (vbx stents) were then placed parallel to the thoracic endograft and flared to the diameter of the target vessel.Medtronic reliant balloon molding of the seal zone was done at the same time as balloon inflation of the vbx stents to reduce gutter leak and prevent crushing of the vbx stents.Completion angiography demonstrated an endoleak that persisted following simultaneous reballooning of the seal zone and a decision was made to reverse the heparin effect and monitor the patient closely.The patient was doing well postoperatively.On post-operative day (pod) 2 a ct-a demonstrated an type ic endoleak caused by pullout of the vbx stent from the right renal artery.The mechanism for this was likely a technical error during the initial placement of the vbx stent.During simultaneous balloon inflation of the proximal aortic seal zone there is a tendency for the chimney stents to ¿foreshorten¿ or pullout of the target renal artery as well as loss of some of the proximal chimney length above the proximal aortic fabric.In this case, after the simultaneous balloon inflation of the proximal seal zone, the right renal chimney stent most likely pulled back from the renal orifice such that a type ic endoleak occurred.The patient was taken back to the operating room and the left proximal brachial artery was surgically exposed.The right renal artery chimney was cannulated and an additional vbx stent was deployed to seal into the existing chimney stent with closure of the leak.The patient was discharged on pod 5 without creatinine elevation or biochemical abnormalities.Post-operative ct imaging at 12 months demonstrates adequate seal and stable aneurysm sac at 8.1 cm with a type ii endoleak from the ima.

Manufacturer Narrative

Conclusion code (b)(4) was removed as physician/author provided the following statement: although i am not at liberty to discuss the patient specifics and i do not have information regarding the device serial numbers and such, i can share with you that the type 1c renal stent pullout was caused not by a failure of the vbx stent, but due to the vbx stent not being placed far enough in the renal artery in this emergency ruptured aneurysm case.The device performed as intended and was easily tested by extension further into the renal artery with another vbx, which in our experience with complex aneurysm repair, has fared very favorably.

Manufacturer Narrative

Case report: multiple chimney endografts (chevar) for ruptured pararenal aortic aneurysm.Jay jennings,1 ld sheahan,2 cc gloss,2 todd r vogel,3 and jonathan bath,3 columbia, mo.Ann vasc surg 2021; 75: 531.E531¿531.E6.Published online 6 april 2021.H6 - code (clinical; impact; problem; component) selection was completed.Code 4581 - type ic endoleak (pull-out of stent from renal artery; reported as technical error).

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13663936
• MDR Text Key: 290549264
• Report Number: 2017233-2022-02782
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

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: 02/09/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 02/09/2022; 04/21/2022
• Supplement Dates FDA Received: 03/29/2022; 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male