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

Catalog Number PHB051002

Device Problems Complete Blockage (1094); Material Deformation (2976)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

H3: other code: the medical device was returned by the user to a third party for evaluation.The level 1 analysis report was shared with gore.The report is being reviewed and evaluated.H6-code b15 and b17: the physician has sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted vascular graft after cleaning) was performed by the third party.The explanted device was not returned to gore for evaluation.Instead, they provided analysis results to gore.Their explant report is being reviewed by gore explant scientists.H6-code b13: additional information to the event, clinical preconditions, and the statements included in the 3rd party´s explant report have been requested from the 3rd party and the explanting physician.The answers are pending.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

On (b)(6) 2016, the patient presented with critical ischemia of the left limb due to a stenosis in the popliteal artery which was treated with a gore® tigris® vascular stent.On (b)(6) 2023, the stent was explanted during an open femoral-popliteal venous bypass surgery to revascularize the left limb.Reportedly the stent was thrombosed.

Event Description

On (b)(6) 2016, the patient presented with critical ischemia of the left limb due to a stenosis in the popliteal artery which was treated with a gore® tigris® vascular stent.On (b)(6) 2023, a part (2 cm) of the 10 cm stent was explanted during an open femoral-popliteal venous bypass surgery to revascularize the left limb.Reportedly the stent was completely obstructed by thrombotic tissue.In the 1st level explant report provided by a 3rd party it is stated that the stent is encapsulated in biological tissue, a strong deformation is visible at the level where the metallic structure of the stent was cut.

Manufacturer Narrative

Cause investigation and conclusion: additional information to the event, clinical preconditions, and the statements included in the 3rd party´s explant report have been requested from the 3rd party and the explanting physician.No further information was provided to gore.A review of the manufacturing records indicated the device met pre-release specifications.The physician has sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted vascular graft after cleaning) was performed by the third party.The explanted device was not returned to gore for evaluation.Instead, they provided analysis results to gore, which was reviewed by gore explant scientists.The stent was completely covered by thick overlying tissue, which limits the level 1 macroscopic analysis of the metallic structure.Given that the device was generally unobservable due to overlying tissue and only a fragment of the device was returned, additional analysis is unlikely to provide additional information.The 3rd party explant explant states that metallic structure is visible in the middle of the lumen, which suggests a strong deformation of the structure.Gore explant scientists evaluated this statement.Only a 2 cm long part of a 10 cm long tigris device was sent to gepromed for evaluation.This means that the device was cut.The deformation was observed at the cut extremity and thus is consistent with cutting the device.Because of this it is our understanding that the reported thrombosis has not been caused by a pre-explant deformation of the metallic structure of the stent.Device occlusion is a known inherent risk of the device.In the present case the device occluded 6.5 years after implantation.In the instructions for use the following is stated: hazards and adverse events device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion, device failure.Adverse event rates, including reinterventions due to loss of patency, are reported in most publications.This safety profile is not always reported in the same time frame or classified in the same manner from one study to another.However, the vast majority of modern clinical studies include a safety endpoint that take into account thrombosis, occlusion, or reintervention rate within 30 days.In the present case the occlusion occurred 6.5 years after the implant procedure for unknown reasons.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of the reported occlusion and assign a root cause.Therefore the present report is being retracted.

• Brand Name: GORE® TIGRIS® VASCULAR STENT
• 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 CENTRAL B/P; 1500 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17180042
• MDR Text Key: 317632523
• Report Number: 2017233-2023-04049
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P160004
• 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
• Report Date: 07/27/2023

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
• Device Expiration Date: 01/24/2019
• Device Catalogue Number: PHB051002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male