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

Device Problem Fracture (1260)

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

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis-report from third party was received and was investigated.The complainant was contacted to ask for further details, but no information was provided yet.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 patient underwent endovascular treatment for a left asymptomatic popliteal aneurysm with a gore® viabahn® endoprosthesis.It was stated that the covered stent was implanted on (b)(6) 2016 and on (b)(6) 2020 after about 3 years and 6 months, the stent was explanted due to thrombosis.The gore® viabahn® endoprosthesis was returned to geprovas, an independent laboratory, for investigation.Sem imaging identified wire fractures.Certain wire fractures appear to be consistent with in-vivo wear.There was no allegation of wire fracture with the initial report.In a conservative approach, gore has decided to report this finding as a reportable malfunction.

Manufacturer Narrative

Multiple times the surgeon was contacted to request further details, including lot-/ serial no.Of device, if the wire fracture was known before explantation, if wire fracture happened during explantation, in attempts to find possible root cause, and if there is a correlation between the thrombosis and the wire fracture.No further details were provided to gore to date.Product history review: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.The explanted device was sent to geprovas institute for investigation.The device evaluation showed the following: the device was fully encased in native tissue (presumptive popliteal artery) and non-observable.The artery was light tan to brown/red with multiple foci of yellow tissue (presumptive adipose) on the abluminal surface.The artery was distended in the mid-region, in a saccular shape (presumptive aneurysmal sac) and narrowed to a significantly smaller size at the extremities (approximately 5-7 mm).Both extremities presented as transected artery.The luminal patency could not be determined with the information provided.Geprovas reported, ¿the lumen seems to be totally obstructed on both sides.¿ to better observe the device, which was fully encased in tissue another post-digest analysis was requested and performed by geprovas.The additional report provided the following observations: prior to digestion, geprovas took x-ray images of the specimen and transected the aneurysmal sac to expose the device for imaging.X-ray imaging displayed the device surrounded by aneurysmal tissue with a c-shaped bend in the mid-region of the device.Multiple wire discontinuities were identifiable on both sides of the device, going away from the aneurysmal sac.Geprovas also transected the aneurysmal sac, prior to digestion, displaying the device fully surrounded by red/brown/tan, unorganized, aneurysmal tissue.Geprovas subsequently digested the tissue from the device and performed post-digestion analysis.Post-digestion analysis showed one gore viabahn endoprosthesis measuring approximately 85 mm (length) x 8 mm (proximal) x 10 mm (distal).The device presented with two areas of bend in a w-shaped manner.Sem imaging of representative wire fractures were requested by gore and provided by third geprovas.Three wire fractures were present near the distal aspect of the device, in the region that was distal to where the device was extending past the aneurysmal sac.Sem imaging of a fracture face from this area was requested and provided by geprovas.Per geprovas, ¿according to the acquired sem images of both faces, this fracture is due to fatigue.Propagation lines of the fissure are visible on both images.¿ when analyzed by gore metallurgist, the surface showed evidence of mechanical smearing, likely due to in-vivo interaction of the opposing wire faces.Five wire fractures were present near the proximal aspect of the device, in the region that was proximal to where the device was extending past the aneurysmal sac.Sem imaging of fracture face was requested and provided by geprovas.Per geprovas, ¿it seems that this fracture is not due to fatigue.Otherwise, we should have observed propagation lines of the fissure.¿ however, when analyzed by gore metallurgist the surface showed evidence of mechanical smearing, likely due to in-vivo interaction with the opposing wire face.The sem image did not support the claim that the fracture was not due to ¿fatigue¿.The exact cause of the wire fracture cannot be determined with the sem images /information provided.Multiple wire discontinuities (exact number not specified) were present along the proximal stent row at extremity b.Extremity b presented in a partially invaginated manner.The disruptions align with the proximal extremity edge, which was transected during the explant process.Multiple areas of radial film wrap disruption were observed along the device.From gross images, x-ray imaging, post-digestion images, and sem-imaging, the material disruption (i.E., radial film wrap disruptions and certain wire fractures, appear to be consistent with in-vivo wear, in a region of anatomical bends with physiologic motion.The wire discontinuities and partial invagination were likely due to manipulation (i.E., cutting/grasping) with surgical instruments (i.E., scissors, forceps), likely used during the explant procedure.The exact cause of the wire fracture cannot be determined with the information provided.In the instruction for use for the gore® viabahn® endoprosthesis the following is stated: ifu warnings: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: 12922274
• MDR Text Key: 281992216
• Report Number: 2017233-2021-02584
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P040037
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male