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

Model Number VBC101002A

Device Problem Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

The following was reported to gore: during treatment of a brachio-basilic arteriovenous fistula in the patient's right arm, angioplasty was performed due to stenosis.The gore® viabahn® endoprosthesis was then placed at the treatment site.Deployment was started and as the deployment line was pulled, the physician stated the deployment line got caught on something and would not release.The device did not expand at the intended location of the stenosis.When the device was being removed over the wire the device started expanding without the deployment line being pulled.The expanded device was removed by hand as it was at or near the access site.A new device was used to complete the procedure with good results and no adverse outcome for the patient.

Manufacturer Narrative

H6.Code 213: review of device manufacturing record history confirmed device met pre-release specifications.H6.Product evaluation results state the entire device was returned with the endoprosthesis separated.Deployment was attempted.The deployment line did not break, but the end appearance is consistent with the report of it getting caught.The proximal end of the endoprosthesis sustained delamination, in-folding, and stent wire damage.This is consistent with the complaint description indicating the endo was removed manually.The manufacturing records were reviewed, and the device lot met all pre-release specifications.G4.Pma/510(k) number was corrected.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11682752
• MDR Text Key: 249995456
• Report Number: 2017233-2021-01868
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623617
• UDI-Public: 00733132623617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130006
• 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
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Model Number: VBC101002A
• Device Catalogue Number: VBC101002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 73 KG