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 01/14/2020

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 the patient underwent endovascular treatment for an asymptomatic popliteal aneurysm with a gore® viabahn® endoprosthesis.It was stated that the covered stent was implanted in 2016 and on (b)(6) 2020 after about 4 years, the stent was explanted in the setting of acute limb ischemia due to the thrombosis of the device.The gore® viabahn® endoprosthesis was returned to geprovas, an independent laboratory, for investigation.Sem imaging identified one wire fracture.Following sem and metallurgical analysis, the exact cause of the wire fracture cannot be determined with the information provided.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).The artery was light tan to brown/red with a large foci of yellow tissue (presumptive adipose) on the abluminal surface.The artery was engorged in the mid-region, in an ovular manner (presumptive aneurysmal sac), and narrowed to a significantly smaller size at the extremities (approximately 2-5 mm).Multi-focal blue sutures were visible to partially visible on the abluminal surface.Two metallic clips were present on the abluminal surface of the artery, one in the mid-region and one near extremity b.Both extremities were transversely transected.A portion of the graft was observable at extremity b.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 by gore 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 to expose the device for imaging.X-ray imaging displayed the device surrounded by aneurysmal tissue with five metal clips present on the native artery.The transected aneurysmal sac showed 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 in two fragments (segment 1 & segment 2).Segment 1 consisted of the majority of the endoprosthesis with only a portion of the distal aspect being removed.The distal extremity was transected and the remaining portion of the endoprosthesis was analyzed as segment 2.Segment 1: dark red/brown to tan biologic staining was present on the abluminal surface, in the mid-region, where the aneurysmal sac was overlying the device.Areas of radial film wrap disruption were observed, in areas near the proximal and distal aspects of where the aneurysmal sac was overlying the device.The distal aspect was transected.Segment 2: geprovas identified three holes, which they concluded as holes created by grasping/pulling with ¿adson-type tissue forceps¿.However, upon further examination the holes were consistent with those created during the manufacturing process.The proximal aspect was transected with an associated hole along the edge of the transection.One wire fracture was also present, along the distal-most stent row.Sem imaging of the 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 a gore metallurgist the surface showed evidence of mechanical smearing, likely due to in-vivo interaction with the opposing wire face.The exact cause of the wire fracture cannot be determined with the sem images /information provided.From gross images all material disruptions (i.E., material transections/cuts, hole), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel/scissors) and grasping/pulling with surgical instrumentation (i.E., hemostat/forceps), likely used during the explant procedure.The radial film wrap disruptions observed are consistent with in-vivo wear.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: 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: 12922278
• MDR Text Key: 281992434
• Report Number: 2017233-2021-02583
• 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

• 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
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/13/2022
• 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: 68 YR
• Patient Sex: Male