MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Catalog Number PAJ080502B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/01/2020

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.Since it is not known which device, if either contributed to the occlusion, the following device is included in the report: catalog number pajr070502b lot and udi information are unknown.

Event Description

In an article titled " endovascular venous outflow redirection in failing arteriovenous hemodialysis access using a combination of covered and interwoven nitinol stents" it states a patient underwent treatment of an av access revision with two gore® viabahn® endoprostheses with propaten bioactive surface.Nine days following the procedure, complete thrombosis of the two gore® viabahn® endoprostheses with propaten bioactive surface occurred.The occlusion was treated by means of thrombectomy and stent relining.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

Manufacturer Narrative

Section a, b, d, g and h updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The device remains in the patient.Consequently, a direct product analysis was not possible.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.As the following device was used as an overlapping system it will be included in this report: gore® viabahn® endoprosthesis (serial # (b)(6); udi # (b)(4)).Simon bradette, mireille méthot, gérald gahide, myriam létourneau-montminy, catherine lalonde, françois côté, guillaume garneau, mathieu béland, endovascular venous outflow redirection in failing arteriovenous hemodialysis access using a combination of covered and interwoven nitinol stents, journal of vascular and interventional radiology, volume 31, issue 11, 2020, pages 1911-1914, issn 1051-0443,https://doi.Org/10.1016/j.Jvir.2020.07.023.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12298510
• MDR Text Key: 265797168
• Report Number: 2017233-2021-02228
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Catalogue Number: PAJ080502B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• 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): Required Intervention; Other
• Patient Sex: Female
• Patient Weight: 49 KG