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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was reported to gore that on (b)(6) 2015, the patient underwent a surgical treatment of infra-renal abdominal aortic aneurysm in which an endoprosthesis was implanted reportedly on (b)(6) 2020, the patient presented with left lumbar pain.The ct-scan showed a left retroperitoneal hematoma developed from the left common iliac artery.Gore® viabahn® endoprosthesis follow-up was marked by iterative interventions; needing the implantation of another stent in 2020 (no information concerning the reason for implantation is provided).On (b)(6) 2020 due to a type i endoleak, an open surgical procedure was required.According to report, there was no allegation against the viabahn and its contribution to the incident.

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The medical device returned to a third party for investigation.The analysis report was shared with gore and evaluated appropriately.Further information related to the procedure, the incident and the patient condition was requested from the hospital and were captured in the adverse event description.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.The information reported in the complaint, including a report from third party lab, does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

During an upgrade to the system, the imdrf codes were inadvertently removed from the original medwatch.

Manufacturer Narrative

H6: corrected imdrf codes.

• 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15291539
• MDR Text Key: 298562670
• Report Number: 2017233-2022-03268
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 11/28/2022
• Supplement Dates FDA Received: 10/03/2022; 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male