MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAC130502E

Device Problems Detachment of Device or Device Component (2907); Premature Separation (4045)

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

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Additional information in regard to the event and images of the case were requested from the physician.The provided additional information is captured in the event description.Investigation is still on going and its result will be provided once its complete.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.

Event Description

According to the report received by gore, this patient underwent an endovascular treatment for an iliac aneurysm in which a gore® viabahn® endoprosthesis was successfully implanted in the iliac artery.During the removal of the catheter, it was discovered that the distal end of the catheter was detached at the transition assembly of the catheter and retained in the sheath.The sheath was a dsf1233 and according to reports, the surgeon did not apply too much force while trying to pull the catheter.In order to retrieve the detached end of the catheter that was stuck in the sheath, the physician had to remove the whole sheath.

Manufacturer Narrative

The engineering evaluation report details observations made directly on the returned device in addition to device photos captured during evaluation.The observation of the detached distal shaft is consistent with the complaint of a detached distal shaft at the transition, and the lack of evidence of a bond further confirms that additional force was not required to cause the separation.Engineering evaluation of the device confirms the reported failure mode.H6: corrected imdrf codes h10: device evaluation summary added.

Manufacturer Narrative

H6: corrected imdrf codes.

Manufacturer Narrative

H1: corrected type of reportable event.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 15594905
• MDR Text Key: 301731493
• Report Number: 2017233-2022-03400
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Catalogue Number: PAC130502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 03/03/2023; 03/17/2023; 03/21/2023
• Supplement Dates FDA Received: 03/15/2023; 03/20/2023; 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male