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

Device Problem Material Integrity Problem (2978)

Patient Problem Aneurysm (1708)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

Analysis-report from third party was received and will be further investigated.Third party was contacted to ask for the exact type and lot- / serial no.Of the device and the relationship to the type iv endoleak.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that the patient underwent endovascular treatment for an asymptomatic thoraco-abdominal aortic aneurysm with two thoracic endoprosthesis and one branched endoprosthesis.It was stated that two covered stents for the celiac trunk and one covered stent for the superior mesenteric artery were used as branch devices.It was reported that one of the covered stents is a gore® viabahn® endoprosthesis with propaten bioactive surface.Reportedly, all endoprostheses were explanted on (b)(6) 2021 due to type ii and iv endoleaks responsible for aneurysmal sac growth.It is not indicated to which of the implanted devices the type iv endoleak is related to.

Manufacturer Narrative

Third party was contacted to ask for the exact type and lot- / serial no.Of the device and the relationship to the type iv endoleak, but to date no further information was provided.Product history review: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Explant scientist observations: the visible graft fragment was reported to measure 15 mm in length with the proximal end within the lumen of the fabric endovascular graft (non-gore) and the distal end situated within the lumen of a non-gore stent graft.The ablumen had scattered plaques of thin light tan to brown tissue with the stent frame clearly visible.A band of light tan tissue was present at the border of the distally overlapping device.The lumen of the graft was not depicted nor reported on thus patency cannot be determined based on information provided.No material disruptions were observed.Request for additional analysis: no.Reason: based on the explant scientist¿s review of the third party report, no additional analysis is requested.Reason for removal of system was for type ii and iv endoleak with no information provided as to which aspect of the system was reportedly involved in type iv endoleak.The stent was reported to be implanted as branch access in the celiac artery which would not likely interact directly with the thoracoabdominal aneurysm.

Manufacturer Narrative

H6: code 4119: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.H6: code 10: the vsx device was investigated and did not find any evidence of a compromised graft structure.Gore was unable to find any evidence to suggest that the type iv endoleak involved the vsx device, but the physician¿s report did not specify which devices were involved and a vsx device was one of the five components.H6: code 22: 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: malposition.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: migration, device failure.

• 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: 12717471
• MDR Text Key: 279021728
• Report Number: 2017233-2021-02498
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 2 THORACIC ENDOPROSTHESES 1 BRANCHED ENDOPROTHESIS; 2 THORACIC ENDOPROSTHESES 1 BRANCHED ENDOPROTHESIS
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male