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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Death (1802)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

This event is from the following literature article: rebonato a, maiettini d, krokidis m, graziosi l, rossi m.Late migration of a covered stent into the stomach after repair of a splenic artery pseudoaneurysm.Journal of radiology case reports 2016;10(2):26-32.No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned; consequently, a direct product analysis was not possible.

Event Description

In the medical literature, an article, "late migration of a covered stent into the stomach after repair of a splenic artery pseudoaneurysm" was reviewed.The splenic artery is the most common location among the spectrum of potential presentation sites of visceral arteries aneurysms and pseudoaneurysms.Endovascular treatment with the use of coils or stents is the first option due to lower morbidity and mortality than open surgery.Endovascular repair may also lead to complications and patients need to be followed up in order to confirm aneurysm sealing, and exclude late complication.It was stated that a (b)(6) patient three years after endovascular repair of a splenic artery pseudoaneurysm was treated with a gore viabahn endoprosthesis.Three months later there was not flow within the stent graft's lumen suggesting thrombosis, but this finding did not raise a concern at this stage, as the patient was stable and the spleen was perfused from collaterals.Three years after the stent insertion, the patient complained of mild abdominal pain and melena; it was revealed endoscopically that the covered stent eroded the stomach wall and migrated into the stomach.The patient was in a palliative pathway and the multidisciplinary board decided to leave the device in situ, given the poor general conditions and short life expectancy.The patient passed away 10 months later without any complications from the migrated stent graft.

• 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 86005
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5564450
• MDR Text Key: 42420054
• Report Number: 2017233-2016-00335
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• 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): Disability
• Patient Age: 76 YR