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

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Test Result (2695)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Literature citation: chaudhuri a, dey r, multi-component parallel endografts at complex tevar may be prone to modular dislocation causing novel endoleaks: a tale of two cases, ejves short reports (2015), http://dx.Doi.Org/10.1016/j.Ejvssr.2015.10.004.Concomitant medical products: alpha thoracic, cook aortic device, 8mm x 10cm gore® viabahn® endoprostheses with propaten bioactive surface no lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remained implanted; consequently, a direct product analysis was not possible.

Event Description

In the medical literature, "multi-component parallel endografts at complex tevar may be prone to modular dislocation causing novel endoleaks: a tale of two cases" was reviewed.Two cases of complex thoracic endovascular aneurysm repair (tevar) with endoleakage due to modular dislocation of multi-component left subclavian parallel endografts in periscope configuration were reported.In this case, a (b)(6) female presented with a 75mm thoracic aortic aneurysm.She underwent a hybrid periscope-tevar procedure using two overlapped thoracic endoprostheses (alpha thoracic, cook aortic) and two 8mm x 10cm gore® viabahn® endoprostheses with propaten bioactive surface.The gore® viabahn® endoprostheses were synchronously deployed as a left subclavian artery periscope via an open brachial approach with an intentioned 2-cm overlap.After 48 hours, the patient was discharged with no complications and a palpable left radial pulse.It was stated that a computed tomography angiogram in the second week post procedure revealed modular dislocation between the two gore® viabahn® endoprostheses with endoleakage into the thoracic aortic aneurysm sac.A repeat computed tomography angiogram at 8 weeks post procedure revealed sac enlargement to 85mm with both components of the left subclavian artery periscope still patent.The patient underwent an urgent re-line of the left subclavian artery periscope.The two components of the periscope were bridged with an 8mm x 10cm gore® viabahn® endoprosthesis with propaten bioactive surface.The completion angiogram revealed no endoleaks and the patient was discharged home with a good left radial pulse, and no neurological complications.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5299944
• MDR Text Key: 33594551
• Report Number: 2017233-2015-00885
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• 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
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR