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

Model Number	VBC101002A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2017233-2021-01868
• Device Sequence Number: 3071266
• Product Code: PFV
• UDI-Device Identifier: 00733132623617
• UDI-Public: 00733132623617
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 73 KG