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

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 10/12/2017

Event Type  Injury  

Event Description

The following article was reviewed: ¿single-center mid-term experience with chimney-graft technique for the preservation of flow to the supra-aortic branches¿ (robert shahverdyan et.Al, vascular, 2018, vol.26 (2), 175¿182, published online on october 12, 2017).The objective of the study was to investigate the feasibility and the mid-term outcomes of the chimney-graft technique for the revascularization of supra-aortic branches in patients with thoracic aortic pathologies involving the aortic arch.A retrospective analysis was done of a prospectively maintained database including all patients with aortic pathologies treated at the institution with chimney/snorkel technique of supra-aortic branches between january 2010 and july 2016.All patients were considered as high-risk candidates for open surgical procedures due to severe cardiac dysfunction, respiratory disorders, previous sternotomy or other medical conditions, and not suitable for arch-hybrid procedure according to the cardiothoracic surgeons within an interdisciplinary conference.A total of 49 supra-aortic branches were revascularised.In particular, a chimney-graft was implanted in the brachiocephalic trunk in 23 patients, in the left common carotid artery in 25 patients and in the left subclavian artery in a single patient.Double-barrel technique was performed in 11 patients, whereas a triple-barrel technique was performed in 19 patients.The conformable gore® tag® thoracic endoprosthesis was used in all but one patient (97%).The article states that one patient had a right common carotid artery - left common carotid artery (lcca) bypass due to an intraoperative dislocation and kinking of a gore® viabahn® endoprosthesis in the lcca.

• 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: joerg kersten ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8173751
• MDR Text Key: 130644555
• Report Number: 2017233-2018-00780
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• 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: 72 YR