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

Device Problem Complete Blockage (1094)

Patient Problem Stenosis (2263)

Event Date 03/17/2019

Event Type  Injury  

Manufacturer Narrative

Unpublished manuscript: outcomes of directional branches using self-expandable or balloon-expandable stent-grafts during endovascular repair of thoracoabdominal aortic aneurysms; authors: emanuel r.Tenorio md phd, jussi m.Kärkkäinen md phd, bernardo c.Mendes md, randall r.Demartino md, thanila a.Macedo md, alisa diderrich rn, jan hofer rn and gustavo s.Oderich md.Reported patient data is based on mean age and percentage.No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remains implanted.Therefore, direct product analysis was not possible.

Event Description

Reviewed was an unpublished manuscript, outcomes of directional branches using self-expandable or balloon-expandable stentgrafts during endovascular repair of thoracoabdominal aortic aneurysms.From 2014 to 2018, a prospective, single-center cohort study was conducted to evaluate outcomes of directional branches using self-expandable stent grafts (sesg) or balloon-expandable stent-grafts (besg) during fenestrated-branched endovascular aortic repair (f-bevar) of thoracoabdominal aortic aneurysms (taaas).A total of 335 renal-mesenteric arteries were targeted by directional branches using sesg (fluency bard or gore viabahn endoprosthesis) in 176 arteries (62 patients) and in 159 arteries (54 patients) received besgs (gore viabahn vbx balloon expandable endoprosthesis).Ten patients had vessels targeted by combinations of both types of stents.The study had 77 males and 49 females; mean age 73±8 years).Technical success was achieved in all patients except one with one 30-day mortality.The one patient was treated for extent ii taaa using besg and died from presumed stroke on postoperative day 23.A pre-dismissal cta (computed tomography angiography) showed widely patent branches and no complications.There were no aortic or branch related deaths during the study.Three stenoses were reported for gore viabahn endoprosthesis implanted in the renal arteries.Further details were requested but not made available.

• 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: genevieve begay ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8737724
• MDR Text Key: 149917070
• Report Number: 2017233-2019-00464
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• 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): Required Intervention
• Patient Age: 73 YR