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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Further information regarding this event was requested from the author but no information was provided.Due to an unknown lot/serial number and no device return, an investigation could not be performed.

Event Description

The literature article: ¿thrombectomy of malignant thoracic central venous occlusive disease using inari clottriever system¿ published by jeffrey forris beecham chick was reviewed.The article was published online or accepted on 09/01/2021.The use of gore® viabahn® vbx balloon expandable endoprosthesis was evaluated for reconstruction of the superior vena cava (svc) and bilateral brachiocephalic veins.In a 2 patient case study, both patients had a reconstruction of the superior vena cava (svc) and bilateral brachiocephalic veins with gore® viabahn® vbx balloon expandable endoprosthesis.Patient 1 was a (b)(6) female.Patient 2 was a (b)(6) female.Patient 2: radiation planning computed tomography 1 day after the procedure showed incomplete stent-graft coverage of the central aspect of the svc as well as suboptimal expansion of the right svc stent-graft.On day 4 after the procedure, the patient underwent bilateral stent-graft relining and central extension using 12-mm by 80-mm abre stents (medtronic, minneapolis, minnesota).The bilateral stent/stent-graft constructs were post dilated using high-pressure 10-mm balloons.The patient was seen on day 10 after the procedure and reported resolution of the swelling and pain.Computed tomographic venography on day 10 after the procedure showed patency of the upper-extremity veins and stent/stent-graft constructs.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14047852
• MDR Text Key: 288875301
• Report Number: 2017233-2022-02851
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female