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); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Renal Impairment (4499); Insufficient Information (4580)

Event Date 05/11/2021

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 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 may 11, 2021.The mean patient age is 73 years and the gender male as stated in the article.The following publication was reviewed: ¿preliminary outcomes of viabahn balloon-expandable endoprosthesis as bridging stent in renal arteries during fenestrated endovascular aortic repair¿ (luca mezzetto, et.Al, journal of endovascular therapy 2021, vol.28(4) 575¿584, published online may 11, 2021).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: ¿preliminary outcomes of viabahn balloon-expandable endoprosthesis as bridging stent in renal arteries during fenestrated endovascular aortic repair¿ (luca mezzetto, et.Al, journal of endovascular therapy 2021, vol.28(4) 575¿584, published online may 11, 2021).The article reports preliminary outcomes of gore viabahn® vbx balloon expandable endoprosthesis (vbx) as bridging stent for renal arteries in fenestrated endovascular aneurysm repair (fevar) between may 2018 and october 2019.26 consecutive patients underwent fevar for complex aortic aneurysm.All patients were classified unfit for open surgery as 23 had an american society of anesthesiologists (asa) score of iii and 3 had an asa score of iv.Cook medical (bloomington, in) aortic endograft was used in all procedures.Vbx was systematically used as the bridging stent for the renal arteries in all patients.The following issues were reported within the article: postoperative acute kidney injury was observed in 5 patients (19.2%), requiring temporary hemodialysis in 2 (7.6%).One of these patients had unilateral renal branch occlusion, with an egfr decrease from >60 ml/min to egfr of 33 ml/min; the other patient had preoperative chronic kidney disease.At discharge, no patients needed permanent dialysis or became dialysis dependent during available follow-up.One occlusion occurred within 30 days after index procedure, in a patient who had previous endovascular aortic repair with suprarenal fixation and on single antiplatelet therapy.An immediate attempt of recanalization by relining or by local fibrinolysis resulted ineffective and a definitive worsening of renal function not requiring hemodialysis was observed.A type ic endoleak was revealed at 6 months of follow-up in a patient with upward plus downward renal arteries orientation; this was treated by means of relining with another vbx stent.Further follow-up was uneventful.

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 and no clinical images enabling direct assessment of product performance were returned for evaluation.No further investigations can be performed.Multiple attempts were made to obtain additional information about these events, such as lot- / serial no.'s, implant dates, patient data and possible root causes.No additional information was provided.With the information provided to gore, the causes for the reported events cannot be established.In the instruction for use for the gore® viabahn® vbx balloon expandable endoprosthesis the following is stated: hazards and adverse events: procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: thrombosis, occlusion.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion and device failure.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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: 14053086
• MDR Text Key: 288875139
• Report Number: 2017233-2022-02852
• 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: 08/12/2022

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: 08/12/2022
• 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: COOK MEDICAL (BLOOMINGTON, IN) AORTIC ENDOGRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male