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

Device Problems Occlusion Within Device (1423); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; perioperative and late outcomes after endovascular treatment for isolated iliac artery aneurysms.Claudio bianchini massoni, antonio freyrie, mauro gargiulo, tiziano tecchio, chiara mascoli, enrico gallitto, gianluca faggioli, rodolfo pini, matteo azzarone, paolo perini, and andrea stella.Ann vasc surg 2017; 44: 83¿93 http://dx.Doi.Org/10.1016/j.Avsg.2017.03.194 fdc24 unsuitable patient morphology.If information is provided in the future, a supplemental report will be issued.

Event Description

Endurant and talent stent graft systems were implanted into a patient for the endovascular treatment of isolated iliac artery aneurysms.Events reported in the journal article: stenosis, common femoral artery intimal flap, inguinal lymphorrhagia.Occlusion within the device, infolding.Abstract: background: the aim of the study is to report early and follow-up outcomes of the endovascular treatment with iliac endografts for i solated iliac artery aneurysms (iiaas).Methods: records of patients who underwent elective endovascular repair for iiaa (both primary and para-anastomotic) from 2005 to 2015 in 2 italian centers were retrospectively examined.Demographic data, preoperative patient comorbidities, iliac aneurysm characteristics, contralateral iliac axis involvement, patency of hypogastric arteries and inferior mesenteric artery (ima), and data of endovascular treatment were obtained for analysis.Early end points were technical success (ts), perioperative morbidity, clinical success (cs), freedom from reintervention (ffr) and survival.Follow-up end points were cs, ffr, survival, evolution of the aneurysmal sac, and endoleak (el).Results: thirty-two iiaas were treated through an endovascular approach in 30 patients (male 96.7%; mean age 74.2 years ± 7.6, range 55e86).Aneurysms were para-anastomotic in 11 (34.4%) cases.Mean diameter was 42.9 ± 15.6 mm (range 30e100).Twenty (62.5%) aneurysms involved exclusively the common iliac artery, 7 (21.9%) the hypogastric, and 5 (15.6%) both arteries.Ipsilateral hypogastric artery was stenotic or occluded in 4 (12.5%) and 1 (3.1%) patient, respectively.Contralateral hypogastric artery was occluded in 2 (6.3%) cases.Ima was patent in 9 (30%) patients.The ostium of the hy pogastric artery was preserved in 5 cases (15.6%) and voluntarily covered in 27 (84.4%).Endovascular embolization of hypogastric artery was obtained with a plug device in 8 cases (25%).Hypogastric surgical revascularization was performed in 2 cases (6.3%).Ts was 96.9%.Thirty-day morbidity was 6.3% (2/32).Cs was 96.9% (1 endograft limb stenosis).Thirty-day ffr was 90.6% (1 transluminal angioplasty, 2 inguinal revisions).Thirty-day survival was 100%.At 1, 3, and 6 years, cs was 93.4%, 85.6%, and 85.6%, respectively (1 endograft limb thrombosis, 1 endograft limb stenosis, 1 hypogastric type ii el with sac enlargement).At 1, 3, and 6 years, ffr was 87.5%, 76.8%, and 76.8%, respectively (1 fibrinolytic therapy and stenting, 1 stenting, 1 surgical ligation of hypogastric artery).At 1, 3, and 6 years, survival was 100%, 96.3%, and 81.3%, respectively.No iiaa related deaths were reported.During follow-up, aneurysmal diameter was unchanged in 12 cases (37.5%), decreased in 19 (59.4%), and increased in 1 (3.1%).Type ii el from hypogastric artery was detected in 3 cases (9.4%) and led to sac enlargement requiring surgical treatment in 1 case.

• Brand Name: TALENT AAA STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 7078302
• MDR Text Key: 94655108
• Report Number: 2953200-2017-01919
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/04/2017
• 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 Age: 74 YR