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 Aneurysm (1708); Hemorrhage/Bleeding (1888); Therapeutic Response, Decreased (2271)

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.(b)(4).

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: 5299954
• MDR Text Key: 33597107
• Report Number: 2017233-2015-00886
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2015
• 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