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

Catalog Number PAH131002B

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Additional 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.

Event Description

The following information was reported to gore: on an unknown date a patient had a central venous catheter (cvc) implanted for dialysis access.On an unknown date this patient had a procedure to create an arterio-venous (av) fistula in the arm for av dialysis access.On an unknown date a stenosis of the brachiocephalic vein was noted.On (b)(6) 2021 the patient underwent a procedure to treat the stenosis by dilating with a 12mm x 40mm balloon, followed by a 14mm x 40mm balloon.A gore® viabahn® endoprosthesis with propaten bioactive surface was advanced over an amplatz ss wire through a 12fr x 45cm cook sheath.During deployment, resistance was felt and the deployment line broke, leaving a portion of the device constrained on the delivery catheter.Attempts were made to fully deploy the device, but these attempts were unsuccessful.The device was then snared and pulled down to the iliac vein, which appeared to compress the left iliac vein.A reintervention to treat the iliac vein and the remaining brachiocephalic stenosis is being planned.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Results code 2: 213: the imaging and engineering evaluations stated the following: imaging evaluation.The image(s) received cannot be used to perform an imaging evaluation due to the insufficient data and/or poor quality of the image(s) provided.Engineering evaluation: product evaluation confirms a broken deployment line.The deployment line break occurred at location approximately 65cm beyond the catheter dual lumen length (120cm).The physical evaluation is unable to identify cause for deployment resistance described by the complaint because the endo and delivery catheter are not available for review.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11361119
• MDR Text Key: 233261602
• Report Number: 2017233-2021-01691
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Catalogue Number: PAH131002B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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; Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 80 KG