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

Device Problems Kinked (1339); Leak/Splash (1354)

Patient Problems Fever (1858); Ischemia (1942); Injury (2348)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; positional changes of an endurant endograft leading to simultaneous ipsilateral iliac limb obstruction and contralateral type iiia endoleak.Nikolaos schoretsanitis, christos argyriou, alexandrina s.Nikova, christina d.Valsamidou, efstratios i.Georgakarakos, miltos k.L azarides, and george s.Georgiadis, alexandroupolis, ann vasc surg 2018; (48): 252.E9¿252.E published online: 6 february 2018 https://doi.Org/10.1016/j.Avsg.2017.10.025.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft system was implanted in a patient for the endovascular treatment of an 95mm infrarenal abdominal aortic aneurysm on an unknown date.The patient was treated outside the instructions for use (ifu) for the endurant stent graft as the proximal aortic neck measured 8 mm in length, of maximum diameter 31 mm, the infrarenal angulation was >60 and the neck morphology was reversed conical (diameter was between 29 and 31 mm for the initial 8 mm and for the next 15 mm was between 31 and 33 mm).Hostile anatomy was observed also in iliac arteries with severe (w90) iliac axis angulation, while the right and left common iliac artery measured 24 mm and 20 mm in diameter, respectively.Additional extensions were placed in the right (due to type ib endoleak) and left (due to short landing zone) iliac arteries, respectively, sealing just before the iliac bifurcation.The final completion angiography confirmed the exclusion of the aneurysm with no signs of any endoleak.It was reported that approximately 5 years post the index procedure, the patient presented emergently with acute left limb ischemia due to the occlusion of the left iliac limb of the endurant endograft.The admission computed tomography angiography revealed also a type iiia endoleak due to modular disconnection of the iliac extensions from the right iliac limb of the endograft main body.An increased kinking of the right limb was observed leading to an almost cross-limb configuration of the limbs had been observed at the 4 year follow up.The ischemia was treated with a femoro-femoral cross-over bypass, and the endoleak was corrected with the position of 2 endurant iliac limb extensions bridging the dislocated endograft pieces.The cause of the event is undetermined.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7410579
• MDR Text Key: 104802107
• Report Number: 2953200-2018-00528
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 04/10/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR