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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Date 05/06/2017

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; perigraft seroma after extra-anatomic bypass: case series and review of the literature daniele bissacco,1,2 maurizio domanin,1,2 silvia romagnoli,1 and livio gabrielli (ann vasc surg 2017; 44: 451¿458) http://dx.Doi.Org/10.1016/j.Avsg.2017.03.201.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii aui stent graft system was implanted in the patient for the endovascular treatment of abdominal aneurysm repair.The patient underwent an endovascular procedure for an 8.25 cm aaa.A left endurant aui stent graft together with a left to right ff ptfe bypass graft were performed.Approximately 1 month after the index procedure, he came back to our department because of a small, painless mass along the femoral-femoral bypass, particularly close to the left section.After 3 weeks percutaneous aspiration was performed and the patient completely recovered.Doppler ultrasound performed 6 months later revealed graft patency and mild asymptomatic recurrence.Background: extra-anatomic bypass (eab) remains a viable alternative for lower limb revascularization if aorto-bifemoral bypass and endovascular therapy are contraindicated.Among eab, perigraft seroma (ps) occurs in about 4% of cases.Diagnostic and therapeutic management, as well as standardized treatment paradigm, are still not well defined.The aim of this study is to report 5 ps cases in eab and to review the literature about similar cases.Methods: we retrospectively reviewed eab performed during the period 2002-2015.Among these, ps cases were analyzed.A similar description for all cases found in the literature through research on the major international databases (pubmed, scopus, embase) was conducted.Results: during the study period, 797 bypasses 528 (66.3%) anatomical and 269 (33.7%) extra-anatomicaldwere performed.Among the latter, 169 femoro-femoral (ff), 20 axillofemoral (axf), 22 axillo-bifemoral (axbf), and 58 aortouni-iliac endoprosthesis (aui) + ff bypasses were performed.Five cases (1.86%) of ps in eab population were detected: 3 after axbf and 2 after aui + ff.Although we initially preferred percutaneous drainage, a surgical choice with graft explant and replacement were imposed by the high recurrence rate.Literature analysis identified 20 additional cases (11 after axbf, 7 after axf and one after aui + ff).Conclusions: our case series and the literature confirm that the most widely used therapy is the surgical drainage with primary or secondary replacement of the graft of a different material.Percutaneous drainage has proved to be ineffective because not conclusive and potential to increase risk of graft infection.Careful follow-up, even years after surgery, remains necessary for ps diagnosis and management, to prevent complications and potential infection.

• Brand Name: ENDURANT II 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: 7099292
• MDR Text Key: 94227968
• Report Number: 2953200-2017-01937
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100021
• 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: 12/08/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/08/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 84 YR