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

Catalog Number PAHR090502E

Device Problem Separation Problem (4043)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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

The following was reported to gore: a viabahn that was used today when the stent suddenly released from the catheter without the operators triggering it.They caught it again with snares and plucked it out with introducers and all.

Manufacturer Narrative

Emdr section h6 codes updated to reflect results of investigation.

Manufacturer Narrative

Product evaluation was completed: the complaint as reported is consistent with the findings during engineering evaluation.The disruption present on the shaft and the rough material at the outer edge of the transition indicates a bond formation.Damage noted on the endoprosthesis is consistent with withdraw of a partially deployed device.The root cause of the reported failure mode could not be established with the available information.The engineering evaluation report details observations made directly on the returned device in addition to device photos captured during evaluation.B5 event description updated.B6/b7 updated patient information.D4 udi number added.D9 date device returned to manufacturer added.H10 product evaluation information was added.

Event Description

The following was reported to gore: on (b)(6) 2024, a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn device) was to be used for treatment of an aneurysm (30mm) in the celiac trunk.As reported, the patient's anatomy was extremely tortuous.A small branch of the hepatic artery originated from the aneurysm (major part was from the sma) and was coiled.It was very difficult to get stability with 8.5fr aptus tourguide sheath and a rosen wire.When it was realized there was not enough support, it was decided to withdraw the viabahn device.However, the viabahn device was unintentionally deployed, even without the physician touching the deployment knob or pulling the deployment line.The viabahn device became stuck, with half in the celiac trunk and half in the aorta.The distal tip was detached and on the rosen wire at the time.The distal tip was snared with an indy snare.The patient was treated successfully with a gore® viabahn® vbx balloon expandable endoprosthesis.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: PFV / SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATME
• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18797456
• MDR Text Key: 336531297
• Report Number: 2017233-2024-04667
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: PAHR090502E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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