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

Catalog Number PAHR061502E

Device Problem Complete Blockage (1094)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  Injury  

Event Description

A study alert was received from viedoc database on november 17, 2021.The following was reported to gore: on (b)(6) 2021, the patient underwent endovascular treatment for a restenotic lesion in the iliac arteries as verified by imaging.A gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device) was implanted in the common- and external iliac artery in the left leg.In addition, a thrombectomy and an endarterectomy were performed in the common femoral artery.At the end of the procedure the device was patent.The patient tolerated the procedure.On (b)(6) 2021 an adverse event happened, as there was a total vessel occlusion.Therefore, a surgical and endovascular repeat intervention was performed on (b)(6)2021.During the intervention there were procedural complications as the vessel re-occluded again.Therefore, a second endarterectomy had to be performed.At the end of the procedure the vsx-device patency was restored.

Manufacturer Narrative

(b)(4).A review of the manufacturing records indicated the device met pre-release specifications.As the device remains implanted in the patient, no further investigation on the device can be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Result of investigation: as the device remains implanted, no further investigation on the device can be conducted.The patient's prior health condition and medication relevant for the incident was collected from the study database.The study coordinator was contacted and asked for the possible root cause, and if there is a relationship to the comorbidities or the patient history of the patient.Concerning the root cause, the physician stated, that a thrombus has been removed.As the entire left iliac artery was occluded including the stents.The patient suffered from factor v leiden, which increases the chance of developing abnormal blood clots most commonly in the legs.Furthermore, it was stated, that the target treatment area was not considered to be a non-compliant lesion.With the information provided to gore, the cause of the complaint was unable to be determined.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: hazards and adverse events procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: thrombosis, occlusion device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13023860
• MDR Text Key: 282718578
• Report Number: 2017233-2021-02616
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2024
• Device Catalogue Number: PAHR061502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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
• Treatment: ADVANTA V12 6X59
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 52 KG