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

Device Problem Device-Device Incompatibility (2919)

Patient Problem Blood Loss (2597)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

The article indicated both gore® viabahn® vbx balloon expandable endoprosthesis & gore® viabahn® endoprosthesis were involved.However, the article did not provide specifics.Reference mdr #2017233-2020-00196 for gore® viabahn® vbx balloon expandable endoprosthesis report.

Event Description

The following published article was reviewed: 'outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts'; emanuel r.Tenorio, md, phd,a gustavo s.Oderich, md,a mark a.Farber, md,b darren b.Schneider, md,c carlos h.Timaran, md,d andres schanzer, md,e adam w.Beck, md,f fernando motta, md,b and matthew p.Sweet, md,g on behalf of the u.S.Fenestrated and branched aortic research consortium investigators, rochester,minn; chapel hill, nc; new york, ny; dallas, tex;worcester,mass; birmingham, ala; and seattle, wash; presented at the 2018 vascular annual meeting of the society for vascular surgery, boston, mass, june 20-23, 2018; 0741-5214; society for vascular surgery.Published by elsevier inc.; https://doi.Org/10.1016/j.Jvs.2019.10.091.The objective of this study was to analyze outcomes of fenestrated-branched endovascular aneurysm repair (f/bevar) for treatment of postdissection and degenerative thoracoabdominal aortic aneurysms (taaas).There were 50 patients (21%) treated for postdissection taaas and 190 (79%) who had degenerative taaas.There were 137 male patients (57%) and 103 female patients (42%), with mean age of 72 years.The article reported that among patients with degenerative taaas, the most common indications for aortic reinterventions were endoleaks in 33 patients (75%; 7 type ic (iliac occluder), 4 type ib (distal), 4 type ii (sac filling), 4 type iiia (junctional separation of the modular components), 9 type iiic (visceral vessel), and 5 combined) or branch-related problems in 9 patients (9%).The article is unclear regarding which devices were used.Note: the article reports the following stents were used as fenestration bridging stents: icast (343), fluency (1), viabahn (3), vbx (2), other (1).The article also reports the following stents were used as directional branch bridging stents icast (116), fluency (97), viabahn (206), vbx (113), other (6).

• 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: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9845174
• MDR Text Key: 193937596
• Report Number: 2017233-2020-00197
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 72 YR