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

Model Number	ENBF2813C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: e nlw1628c124e, serial/lot #: (b)(4), ubd: 25-apr-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of a 50mm abdominal aortic aneurysm.It was reported that the patient presented emergently approximately 7 years post the index procedure with abdominal pain.A ct showed a 9cm abdominal aneurysms and it was noted that the endurant limbs had pulled up into the aneurysm sac and a type ib endoleak was present.The patient was treated with limbs extending down into the hypogastric arteries bilaterally and no endoleak was observed on final angiogram.As per the physician, the cause of the event was anatomy related due to tortuous anatomy.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported bilateral limb migration out of the iliac arteries, with resulting type ib endoleaks and aaa expansion, was confirmed from the films provided.The cause appears most likely to be anatomy related.Review of returned pre-implant ct¿s revealed that the patient had a 46mm maximum diameter infrarenal aaa.The 24mm diameter aortic neck was moderately angulated ~45 deg a-p x 45 deg rt-lt.The flow lumen diameter at the level of the distal aorta measured 33 x 18 mm.The right common iliac was moderately tortuous, aneurysmal, and contained thrombus; the rcia diameter ranged from 24 ¿ 25 ¿ 13mm.The left common iliac was straight with slight thrombus, and ranged in diameter from 15 ¿ 10 ¿ 13mm.Earlier follow-up images were not provided.Ct¿s returned from 7-½ years post-implant revealed that the maximum diameter aaa had increased to 84mm.Contrast was seen within the distal sac coming from bilateral type ib endoleaks; both limbs had pulled out of the iliacs and were floating within the distal sac.The infrarenal neck angulation had increased to ~70 deg a-p x 70 deg rt-lt, the distal aorta had dilated to ~70mm, and the right common iliac artery was also aneurysmal.Both iliacs were moderately tortuous.The rcia measured ~48mm max diameter, and narrowed down to ~13mm in diameter near the right iliac bifurcation, and the lcia ranged in diameter from 17 ¿ 9 ¿ 16mm.It appears likely that disease progression (iliac artery dilatation) as well as aneurysm morphology changes (increased vessel angulation) both contributed to the limbs pulling out of the common iliac arteries.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8230635
• Report Number: 2953200-2019-00061
• Device Sequence Number: 11168040
• Product Code: MIH
• UDI-Device Identifier: 00613994762191
• UDI-Public: 00613994762191
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2013
• Device Model Number: ENBF2813C166E
• Device Catalogue Number: ENBF2813C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 70