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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

Endoleak.Dislocation of the branch stent graft leading to endoleak.The devices remain implanted in the patients.Please be informed that within the reviewed literature article in total three reportable type of incidents were determined.They are reported with gore reference numbers (b)(4).

Event Description

The following literature article was reviewed: "custom-made endograft for endovascular repair of thoraco-abdominal aneurysm and type b dissection: single-centre experience"; pierleone lucatelli et al.Journal of the cardiovascular interventional radiology (2018) 41:1174-1183 published: may 03, 2018.A retrospective analysis of patients treated with an e-xtra design engineering endograft from jotec gmbh (hechingen, germany) was performed to identify predictive factors for re-intervention.From january 2011 to january 2017, 49 patients received endovascular treatment with the jotec custom-made endograft for a thoraco-abdominal aneurysm crawford type 1 or 2 or 3 or 4, or a type b dissection due to chronic aneurysmal dilatation of the false lumen.The custom-made device was deployed via a surgical cut down of the femoral artery in all cases.Completion of 55 fenestrations was performed with balloon-expandable covered stents (advanta v12, maquet holding, germany), whereas 97 branch completions were performed with self-expandable covered stents (viabahn, gore & associates, flagstaff, usa).Catheterization of the visceral vessel branches and stenting was performed via a surgical left femoral access for an antegrade approach.Retrograde branches were used in case of complex aortic morphology or in patients in which technical constraints did not allow antegrade orientation, e.G.Two closely positioned branches.Associated surgical interventions: carotid-subclavian bypass (1), femoro-femoral bypass (1), common femoral endarterectomy at the access site (3).Branch reconstructions were performed for coeliac trunk, superior mesenteric artery, right and left artery, assessor renal artery and inferior mesenteric artery.Within 30 days after the procedure, 3 reintervention were performed due to dislocation of the branch stent graft leading to endoleaks.

Manufacturer Narrative

A2: patient age: 71 = mean age provided in the article.A3: patient gender: vast majority is male.B3: date of event is unknown, so the publishing date was used as date of event.D6: as a best estimate the starting date of this study is used as the date of implant.E: complainant phone number cannot be obtained.H6-code 4119: the lot numbers have not been provided.H6-code 3221: review and analysis of all available information fails to indicate a potential root cause of the incident as reported to gore, as the lot numbers remain unknown and the devices remain implanted in the patient.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8947727
• MDR Text Key: 160873700
• Report Number: 2017233-2019-00775
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR