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

Catalog Number VBHR062502A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/20/2023

Event Type  malfunction  

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.A4; b7: patient weight, relevant medical history and medications were requested but not made available.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b18: the device was discarded at the user facility; therefore, analysis could not be conducted.No images enabling direct assessment of product performance were returned for evaluation.Instructions for use for gore® viabahn® endoprosthesis with heparin bioactive surface warnings section state: do not withdraw the gore® viabahn® endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® endoprosthesis back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® endoprosthesis or introducer sheath.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: during treatment of a stenotic occlusion in the patient's left superficial femoral artery, access was made from the contralateral side.A 7fr x 45cm terumo sheath was used to advance the first gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) over a.035 guidewire (brand not specified).As reported, the physician did not pre-dilate the stenotic occlusion and was pushing the device with some force.However, the device did not cross the lesion.The viabahn device was pulled back through the sheath.After dilating the target lesion, the same viabahn device was advanced again and was deployed.When pulling the catheter back through the sheath, the distal tip got caught at the edge of the sheath and the catheter broke.As reported, the broken piece was pulled out through the sheath as it was near the opening of the sheath.It was reported the delivery catheter separation was at the sheath opening and it was close enough to pull out manually.A second viabahn device was implanted, overlapping the first device in the same anatomical location.The patient is reported to be doing well following the procedure.

Manufacturer Narrative

Ifu was reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statements were identified as related to the failure mode(s) in this complaint: while maintaining the position of the guidewire across the treated lesion, carefully withdraw the delivery catheter through the lumen of the endoprosthesis and remove it via the introducer sheath.Moderate resistance may be felt when the distal tip is withdrawn through the introducer sheath.Note: if, during catheter removal, the tip catches on the leading edge of the endoprosthesis or introducer sheath, a slight ¿back and forth¿ motion of the catheter or repositioning of the sheath may aid in release.Excessive or abrupt force during catheter removal may damage the endoprosthesis, delivery catheter, or introducer sheath.Gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device/vsx device) was not returned, but product evaluation task was completed with the following results: the primary reported complaint of vsx device distal catheter shaft breakage was confirmed by photographs provided from the field.It was reported that the vsx device was discarded and was unavailable for evaluation.According to the information provided, the distal shaft separation occurred during withdrawal when the distal tip of the vsx device delivery catheter got hung up on the distal end of the introducer sheath.Due to the potential for excessive or abrupt force during catheter removal to cause damage to the endoprosthesis, delivery catheter, or introducer sheath, the vsx device instructions for use provide special instructions for this circumstance to aid in release of the vsx device.The cause of the confirmed distal shaft breakage is consistent with the potential use error of forceful withdrawal of the vsx device delivery system.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18333046
• MDR Text Key: 330968502
• Report Number: 2017233-2023-04472
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132622863
• UDI-Public: 00733132622863
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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: VBHR062502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male