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

Catalog Number BXA082902E

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the study no.Including hospital and patient.As the device remains implanted, an investigation of the device cannot be performed.The product history review: a review of the manufacturing- , sterilization- and boxing records indicated the device met pre-release specifications.The event is ongoing and not resolved yet.The study coordinator was contacted and further details requested, such as what is the cause for the occlusion of the vbx-device, what will be done to solve the issue and if a reintervention is necessary.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 to gore that the patient underwent endovascular treatment on (b)(6) 2020 for a thoracoabdominal aneurysm type iv.A three times branched endovascular aortic repair (bevar) was performed with a cook t-branch endovascular graft as main aortic body and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device) was implanted each in the right renal artery, in the celiac artery, in the superior mesenteric artery and in the subclavian artery.It was stated that on (b)(6) 2022 an ultrasound was performed and an occlusion in the celiac artery was found.

Manufacturer Narrative

H1 type of reportable event should be "other".Review of new provided information from the hospital changes this event to not-reportable per our gore® viabahn® vbx balloon expandable endoprosthesis worldwide reporting guidelines, as the physician stated that a ct scan revealed that there is no occlusion in the celiac artery and that the data in the study database was corrected accordingly.The question in the study database "are the vbx-device(s) patent?¿ was now answered with yes.As there is no allegation of a serious injury or malfunction of the gore® viabahn® vbx balloon expandable endoprosthesis in question anymore per our worldwide reporting guidelines, this event is considered not reportable.Therefore the report is being retracted.

• 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: 15119633
• MDR Text Key: 296758220
• Report Number: 2017233-2022-03167
• 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,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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
• Device Expiration Date: 08/05/2022
• Device Catalogue Number: BXA082902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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
• Treatment: COOK T-BRANCH ENDOVASCULAR GRAFT.
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 76 KG