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

Catalog Number PAH081002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Ischemia (1942); Necrosis (1971); Thrombus (2101)

Event Date 03/11/2016

Event Type  Death  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.(b)(4).As w.L.Gore & associates was informed that during the procedure three conformable gore® tag® thoracic endoprostheses were implanted beside the three gore viabahn® endoprostheses, gore is submitting also a report (2017233-2016-00549) for one of the implanted conformable gore® tag® thoracic endoprosthesis.

Event Description

On (b)(6) 2016, the patient was implanted with three conformable gore® tag® thoracic endoprostheses to treat a thoraco ¿ abdominal aortic aneurysm.The procedure also involved three viabahns which were implanted into the superior mesenteric artery (sma) and one each into the right and left renal artery.There were no issues noticed during the procedure.On the third day post procedure, the patient developed abdominal pain.In a side branch of the mesenteric artery, computed tomography angiography revealed that a thrombus had formed 3 to 4 cm away from the location were one of the viabahns had been implanted into the sma.Although laparotomy and embolectomy were immediately performed, the patient subsequently died due to irreparable ischemic and necrotic damage in the coecum and in the small bowel caused by the thrombus formation.The reason for the thrombus formation is unknown.

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5696980
• MDR Text Key: 46491401
• Report Number: 2017233-2016-00548
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2018
• Device Catalogue Number: PAH081002
• Device Lot Number: 14710935
• 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: 12/18/2015
• 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: 75 YR