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

Model Number	ETBF2316C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 51 mm abdominal aortic aneurysm.The proximal aortic neck diameter measured 19-21 mm with a neck length of 30mm.The diameter at the level of the aortic bifurcation measured 31 mm.It was reported during the index procedure after the stent graft system was implanted, final angiogram showed that the bifurcated graft was partially covering the left renal artery.Additionally, an endoleak was appreciated at the level of the contra-lateral gate.The physician felt the endoleak could be junctional related and re-ballooned the overlapping segment of the contra-lateral limb.A repeat angiogram demonstrated persistent endoleak at the same level so the physician decided to re-evaluate at later date.An additional angiogram was performed to confirm the proximal location of the stent graft.The left renal artery was filling but was partially covered so the physician elected to implant a 7x20mm balloon expandable stent.A final angiogram demonstrated gross patency of the left renal artery and the procedure was completed.Per the physician the cause of the renal occlusion was due to user error.The cause of the type iiia endoleak is undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: as per the physician, the cause of the type iii endoleak could not be confirmed but it was suspected that it was due to calcification of the distal aortic bifurcation.Analysis summary: the cause of the reported inaccurate (high) placement of the bifurcate leading to partial coverage of the left renal artery could not be determined.The cause of the endoleak reported at implant near the contralateral gate also could not be determined.Images during implant were not provided and the reported events could not be assessed.In addition, post-implant ct¿s were not available for evaluation of the stent graft in-vivo configuration.Analysis of the returned films did not reveal any anatomical characteristics that could explain the reported events.It is possible that the inaccurate delivery was user related.The exact type and cause of the endoleak seen during the procedure could not be determined from the films provided.Angiograms showing the endoleak (including endoleak interrogation) were not provided which could have assisted with a more comprehensive determination of the endoleak source/cause.This may have been a type iiia junctional endoleak due to insufficient component overlap.While a type iiib fabric endoleak cannot be ruled out, this appears most likely to have been an acute type iv blush endoleak caused by fabric porosity.Other factors such as heparin dose, outflow resistance, and volume of the aneurysm sac may have also contributed to this possible type iv endoleak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II 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: 9361658
• Report Number: 9612164-2019-04861
• Device Sequence Number: 2606438
• Product Code: MIH
• UDI-Device Identifier: 00613994991201
• UDI-Public: 00613994991201
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 10/08/2021
• Device Model Number: ETBF2316C145E
• Device Catalogue Number: ETBF2316C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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