MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR TALENT AAA STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number UNK-CV-SR-TAL AAA

Device Problems Bent (1059); Leak/Splash (1354); Malposition of Device (2616)

Patient Problem Occlusion (1984)

Event Date 02/17/2015

Event Type  Injury  

Event Description

Medtronic received the following information obtained from the journal article entitled: type ii endoleak prevention with coil embolization during endovascular aneurysm repair in high-risk patients.Dominique fabre, md, elie fadel, phd, philippe brenot, md, sarah hamdi, md, abel gomez caro, md, sacha mussot, md, jean-pierre becquemin, md, and claude angel, md.(journal of vascular surgery (2015).Http://dx.Doi.Org/10.1016/j.Jvs.2015.02.030).Between january of 2009 and december 2013 an endurant and talent stent graft system were implanted for the endovascular treatment of a abdominal aortic aneurysm.The following adverse events were observed: type ia which required a cuff placement, distal stent graft kinking, and an inadvertently covered left renal artery.Objective: this study evaluated endoleak level and size decrease of infrarenal abdominal aortic aneurysm (aaa) after endovascular aneurysm repair (evar) with coil embolization in patients at high risk for type ii endoleak.Methods: between 2009 and 2013, 83 of 187 patients (44.3%) who underwent evar for aaa also underwent coil embolization of the aneurysm sac immediately after complete stent graft release because of risk factors for type ii endoleak, including absence of a circumferential thrombus, two or more pairs of patent lumbar arteries, or a patent inferior mesenteric artery.Coil embolization was achieved using a 4f catheter with a microcatheter placed between the stent graft and the aneurysm wall.Computed tomography and color duplex ultrasound imaging were performed 1, 6, 12, and 24 months later to look for an endoleak and assess aneurysm sac diameter.Results: mean follow-up was 24 6 11 months (range, 6-53 months).A mean of 12 coils (range, 4-23) was used.Technical success was achieved in all patients, with no procedurally related complications.Follow-up computed tomography showed type ii endoleak in one patient.Aneurysm sac diameter was significantly decreased after 6 months (p[.001), 12 months (p [.001), and 24 months (p [.001).Surgery was required in one patient for common femoral artery occlusion unrelated to the procedure and in another patient for distal type i endoleak.Conclusions: aneurysm sac coil embolization during evar for patients at risk for type ii endoleak is technically feasible, safe, and effective in preventing type ii endoleak.This procedure leads to rapid aaa shrinkage.Thus, coil embolization could be used routinely to improve evar outcomes for patients at risk for type ii endoleak.(j vasc surg 2015;-:1-7.).

Manufacturer Narrative

(b)(4).

• Brand Name: TALENT AAA STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 4779448
• MDR Text Key: 5799982
• Report Number: 2953200-2015-00905
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P070027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-TAL AAA
• Device Catalogue Number: UNK-CV-SR-TAL AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/18/2015
• 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: 00074 YR