MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

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

Patient Problem Stroke/CVA (1770)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: cook thoracic device.

Event Description

The following information was reported to gore: in a literature article titled "total endovascular repair of contained ruptured thoracoabdominal aortic aneurysms", it states two patients who were implanted with gore® viabahn® endoprostheses had complications.The first patient, designated as case # 9 in the article, was treated with parallel grafting with a gore thoracic endograft and a gore® viabahn® endoprostheses for the celiac trunk, superior mesenteric artery, and right renal artery reinforced by bare metal stents.This patient had a cardiac complication (myocardial infarction and atrial fibrillation) that required prolonged recovery in the intensive care unit and adjunctive medical therapy.This patient died on post-operative day 15, due to cardiac complications.(captured event # (b)(4)).The second patient, labelled as case # 10 underwent a triple chimney technique procedure by bilateral axillary approach.A cook thoracic device was utilized with gore® viabahn® endoprostheses for the celiac trunk, superior mesenteric artery, and right renal artery reinforced by bare metal stents.On post-operative day 2 this patient had a minor stroke with dysphasia and superior arm hyposthenia.The cerebral ct showed an ischemic lesion and the patient completely recovered his functional status on post-operative day 15.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• 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: heidi inskeep ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8976746
• MDR Text Key: 157396804
• Report Number: 2017233-2019-00826
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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 the Report Sent to FDA?: No
• 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): Hospitalization; Other
• Patient Age: 74 YR