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

Model Number	ETBF2813C145E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: etlw1613c124e, sn (b)(4), expiration date: 2018-11-10, udi # (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.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 a 5 cm in diameter abdominal aortic aneurysm.It was reported the patient returned for follow up.The ct revealed that the left endurant iliac limb was occluded up to the flow divider.The physician elected to perform thrombolysis within the stent grafts.The occlusion was corrected and blood flow was restored.The physician cannot determine the cause of the event.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the left limb occlusion could not be determined from the films provided.Angio¿s at implant were not available for review; the blood flow dynamics could not be assessed from the ct¿s provided.The pre-implant films returned revealed that the patient had a 25mm diameter distal aortic which was extremely calcified; 15 ¿ 20mm flow lumen diameter.Films returned from 5 weeks post-implant revealed that thrombus was observed along the inner wall of the bifurcate aortic body, and the left/contra limb was 100% occluded beginning at the flow divider.Blood flow reconstituted distally at the left iliac bifurcation.The right limb was patent.Within the distal aorta the left/contra limb was observed to be compressed down to 7mm id (10mm od), and at the distal end the 13mm nominal diameter limb narrowed down to ~6mm id (8mm od).It is possible that the iliac limb compression within the calcified distal aorta and distal segment of the lcia which resulted in a diameter restriction, contributed to the occlusion due to the flow restriction.This may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.
Additional Manufacturer Narrative
Corrected information: sex, date of birth, no eval explain code.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: 6392623
• Report Number: 2953200-2017-00354
• Device Sequence Number: 798047
• Product Code: MIH
• UDI-Device Identifier: 00613994991294
• UDI-Public: 00613994991294
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2018
• Device Model Number: ETBF2813C145E
• Device Catalogue Number: ETBF2813C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided; 03/30/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/19/2017; 09/29/2017
• 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: 76 YR