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

Catalog Number VBJ081002

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Aneurysm (1708); Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Ischemia (1942); Thrombosis (2100); Test Result (2695)

Event Date 08/18/2014

Event Type  Death  

Event Description

On (b)(6) 2014, a conformable gore® tag® thoracic endoprosthesis (c-tag®) was implanted in a patient.The patient had a large descending aneurysm close to the aortic arch.The c-tag® migrated distal in the aorta out of arch and into proximal descending segment.It was stated that the patient¿s specific extreme anatomy was the suspected cause of the migration.On (b)(6) 2014, a re-intervention was performed to extend the devices.Two gore® viabahn® endoprostheses with heparin bioactive surface were implanted in the superior mesenteric artery (sma) and the left renal artery along with two c-tag® devices in a sandwich procedure.A thrombectomy procedure was performed prior to the implantation.Immediately after the procedure the patient¿s platelet count dropped precipitously low from 275k to 25k - 30k.It was stated that the drop in platelet count was believed to be related to dic and consumptive coagulopathy due to the post implant process and the massive aneurysm.It was reported to gore that the patient expired on (b)(6) 2014.The cause of death was believed to be bowel ischemia.The day prior to death, a ct was performed that showed pneumatosis within the bowel loops and an apparent clot at the confluence of the splenic, sma and portal veins.It was also stated that the mesenteric ischemia was believed to be related to poor perfusion of the sma and the partially thrombosed gore® viabahn® endoprosthesis with heparin bioactive surface.It was stated that the thrombosis likely occurred when the proximal c-tag® (outer layer of ¿sandwich¿ graft configuration) shifted down and moved both the left renal artery and sma stent grafts (middle of sandwich) to below the inner c-tag layer of the sandwich which covered the tops of the branch gore® viabahn® endoprostheses.

Manufacturer Narrative

Concomitant medical products: additional gore® viabahn® endoprostheses with heparin bioactive surface: vbj061002/12869794, vbj061002/12869795.Ctag® devices: tgu282815/12346638, tgu282815/11588086, tgu343410/12789706, tgu312610/12236438.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was not returned; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.".

• 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 86004 ; 9285263030
• MDR Report Key: 4596956
• MDR Text Key: 17204970
• Report Number: 2017233-2015-00153
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: VBJ081002
• Device Lot Number: 11094737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2013
• 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): Death
• Patient Age: 76 YR