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

Catalog Number PAJR062502E

Device Problem Complete Blockage (1094)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 06/30/2023

Event Type  Injury  

Event Description

Reportedly, on (b)(6) 2023, this patient underwent an endovascular treatment for an occlusive peripheral vascular disease (pad) in the right proximal superficial femoral artery that was treated with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® device).Vascular access was gained through the left common femoral artery.A laser atherectomy was performed prior to viabahn® device placement.The viabahn® device was successfully navigated and deployed in the intended location.Post-dilation performed along the viabahn® device using a 5 mm percutaneous transluminal angioplasty (pta) balloon.The delivery catheters were successfully removed and the patency of the viabahn® device was confirmed at the end of the procedure.According to study database entries, on (b)(6) 2023, an acute distal limb ischemia with distal embolization that occurred secondary to an occlusion of the viabahn® device due to thrombosis of the stented femoro-popliteal segment.The patient therefore underwent a reintervention including thrombolysis followed by stenting of the popliteal segment and relining of the viabahn® device.Reportedly, the physician was convinced that distal stent segment of the viabahn® device was inadequately dilated during the initial procedure and that the distal embolization, that was associated with the laser atherectomy performed during primary procedure, contributed to the thrombosis of the stent.

Manufacturer Narrative

H6-b15 and b13: the study database was review and a request was sent to the study coordinator to provide further information to the event.The collected information is captured in sections a through d.H6-b14 and c19: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.H6-b20: the device remains implanted in the patient.Therefore a device evaluation could not be performed.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

Cause investigation and conclusion: the study database was review and a request was sent to the study coordinator to provide further information to the event.The collected information was captured in sections 2.And 3.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Based on the event description and the subsequent investigation we are unable to determine the cause of this incident and assign a root cause.The risk management documents for the gore® viabahn® endoprosthesis with propaten bioactive surface were reviewed.No potential new or different reasonably foreseeable risk related to the device or its use were identified based on this event.The benefit of the product has been assessed against the overall residual risk and determined that the benefit of the product outweighs the risk to the patient.Ongoing risk/benefit assessment and acceptability of residual risk serves to reaffirm risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore monitors complaints closely to ensure that risks remain within the bounds estimated in the risk management documents.The reported information does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.The reported device occlusion represents a known complication or adverse event that can occur when using stent-graft endovascular devices which can result from several factors including intraprocedural technical considerations, post-operative follow-up and treatment regimen, patient-related risk factors and disease progression.In the instructions for use the following is stated: adverse events: possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with propaten bioactive surface or in any endovascular procedure and require intervention include, but are not limited to: occlusion (thrombosis and/or stenosis) of endoprosthesis or vessel; ischemia.It was reported to gore, that the physician was convinced that the distal stent segment of the viabahn® device was inadequately dilated during the initial procedure and that the distal embolization, that was associated with the laser atherectomy performed during primary procedure, contributed to the thrombosis of the stent.This indicates that the occlusion of the viabahn® device may be associated with the procedure and the subsequent events related to ischemia and formation of thrombus.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17585031
• MDR Text Key: 321547915
• Report Number: 2017233-2023-04217
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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 Catalogue Number: PAJR062502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female