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

Catalog Number BXA065902E

Device Problem Obstruction of Flow (2423)

Patient Problems Pain (1994); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Renal Impairment (4499)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

It was reported that on (b)(6) 2021, the patient presented with a thoracoabdominal aortic aneurysm class iv that was treated with one gore® excluder® thoracoabdominal branch endoprosthesis, one gore® excluder® aaa endoprosthesis and five gore viabahn® vbx balloon expandable endoprostheses that were used as side branch components (superior mesenteric artery: 1; celiac artery: 1; left renal artery: 1; right renal artery: 2).Once the implant procedure was completed, but prior to the patient leaving the operating room, it was noted that the patient¿s left leg was ischemic.The patient therefore underwent a left popliteal embolectomy to remove the arterial thrombus and atherosclerotic embolic debris.The entire procedure was successfully completed.The patient tolerated the procedure.On (b)(6) 2021, the patient presented with acute back pain which was treated with morphine.Acute kidney injury because of bilateral renal artery stent thrombosis was noticed.The patient underwent transcatheter embolectomy and catheter directed thrombolysis of the renal branches.The right renal artery could be cleared, but there was no good runoff into the parenchyma.Attempts to cannulate the left renal artery were abandoned without resolving the thrombus given difficult anatomy and physiological deterioration.It was reported that the patient continued to be in acute renal failure due to the lack of perfusion of both kidneys.The patient received haemofiltration and then haemodialysis.A ct scan undertaken on (b)(6) 2021, shows that there is some preservation of lower pole perfusion of the right kidney due to an accessory artery.The left kidney enhances better than the right.Some recovering residual renal function was noted.The patient continues to receive intermittent haemodialysis through a tesio line.Reportedly, the patient developed a pseudoaneurysm of his left brachial artery which had been used for attempted percutaneous thrombolysis of the renal branches.A thrombin injection of this was undertaken on (b)(6), 2021.Tingling an numbness of the fingers of his left arm continued.Therefore they undertook an evacuation of the brachial haematoma on (b)(6) 2021.The symptomatology improved following this.

Event Description

It was reported that on (b)(6) 2021, the patient presented with a thoracoabdominal aortic aneurysm class iv that was treated with one gore® excluder® thoracoabdominal branch endoprosthesis, one gore® excluder® aaa endoprosthesis and five gore viabahn® vbx balloon expandable endoprostheses that were used as side branch components (superior mesenteric artery: 1; celiac artery: 1; left renal artery: 1; right renal artery: 2).The procedure was successfully completed.The patient tolerated the procedure.On (b)(6) 2021, the patient presented with acute back pain which was treated with morphine.Acute kidney injury because of bilateral renal artery stent thrombosis was noticed.The patient underwent transcatheter embolectomy and catheter directed thrombolysis of the renal branches.The right renal artery could be cleared, but there was no good runoff into the parenchyma.Attempts to cannulate the left renal artery were abandoned without resolving the thrombus given difficult anatomy and physiological deterioration.It was reported that the patient continued to be in acute renal failure due to the lack of perfusion of both kidneys.The patient received haemofiltration and then haemodialysis.A ct scan undertaken on (b)(6) 2021, shows that there is some preservation of lower pole perfusion of the right kidney due to an accessory artery.The left kidney enhances better than the right.Some recovering residual renal function was noted.The patient continues to receive intermittent haemodialysis through a tesio line.

Manufacturer Narrative

H6-code 213: images have been provided for evaluation.The imaging evaluation summary states the following: all stent graft vbx devices within the renal arteries are occluded on the (b)(6) 2021 cta study.There appears to be a small amount of collateral flow distal of the occlusion in the left renal artery.The right accessory renal artery appears to be patent and connected to the endoleak.There appears to be type ii endoleaks involving the ima and right accessory renal artery.B4: updated description.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12546330
• MDR Text Key: 273764089
• Report Number: 2017233-2021-02407
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Catalogue Number: BXA065902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2019
• 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): Hospitalization; Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 112 KG