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

Catalog Number VBH080202W

Device Problems Premature Activation (1484); Separation Problem (4043)

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2024, a patient was implanted with 8mm x 2.5 gore® viabahn endoprosthesis with heparin bioactive surface (viabahn device) to treat celiac trunk dissection.The physician planed to reline 5mm x 5cm and 8mm x 2.5 viabahn device.Firstly 5mm x 5cm viabahn device was successfully deployed in common hepatic artery.Then 8mm x 2.5 viabahn device was advanced via long sheath through guidewire into celiac trunk.However, the 8mm x 2.5 viabahn device couldn't get into the distal end of 5mm x 5cm viabahn device.Then the physician tried to withdraw 8mm x 2.5 viabahn device into long sheath.After multiple attempts, it couldn't be retrieved into sheath.Therefore, it was removed with long sheath in tandem.When it got into left common iliac artery, the stent was partially expanded, and distal tip was detached with catheter.A snare was utilized to capture distal tip and catheter out of patient.As the diameter of stent was smaller than left common iliac artery, it was moved to left common femoral artery.There was no coverage of other vessel.The patient tolerated the procedure with no adverse experience.

Manufacturer Narrative

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.

Manufacturer Narrative

C19: the manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.Product investigation report conclusion : due to the inability to replicate the exact clinical conditions within a laboratory setting, the primary failure mode ¿ difficulty to advance through a previously implanted device ¿ cannot be evaluated.Therefore, engineering evaluation of the returned vsx device could not confirm the reported primary failure mode; the root cause of the reported primary failure mode could not be established with the available information.The reported failure mode related to an unintended partial expansion of the device was confirmed following an imaging evaluation of returned clinical items.Imaging evaluation findings demonstrated that a still capture from the video showed a partially open/deployed device.Users are instructed in the ifu to withdraw the vsx device to a position close to the introducer sheath rather than withdrawing it into the sheath, then removing both in tandem.Per the ifu, withdrawing the vsx device back into the sheath can lead to various issues including premature deployment.As reported, the physician attempted to withdraw the vsx device into the sheath multiple times unsuccessfully before removing in tandem with the sheath, after which the reported partial expansion occurred.Therefore, the root cause of the reported unintended partial device expansion is consistent with use error as reported from the field.Engineering evaluation of the vsx device could not confirm the reported failure mode of distal tip separation as the distal shaft and distal tip of the vsx device were not returned.Engineering evaluation observed separation at the transition; however, it was noted that there was a bond present at that location, confirming that a bond was formed during the manufacturing process.Engineering evaluation was inconclusive about the nature or magnitude of stresses that caused the breakage to occur.However, the aforementioned ifu instruction advises against withdrawing the device through the sheath due to the potential for consequences including catheter separation.The transition bond separation was reported to have occurred following multiple unsuccessful attempts by the physician to withdraw the vsx device into the sheath.Therefore, the root cause of the reported transition bond separation is consistent with use error as reported from the field.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18490498
• MDR Text Key: 333198102
• Report Number: 2017233-2024-04536
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBH080202W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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 Age: 57 YR
• Patient Sex: Male