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

Model Number	ETLW1620C93E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	08/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 60mm diameter abdominal aortic aneurysm.It was reported that a routine 6 month follow up doppler ultrasound scan was performed.During the scan, the physician identified right limb occlusion.At this time the patient complained of tiredness and numbness of the right leg, but these symptoms have since resolved.The cause of the event cannot be determined, as per the physician.The physician stated that the patient will receive no further treatment or intervention at present.
Additional Manufacturer Narrative
No additional clinical sequelae were reported and the patient will be monitored by their physician.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Films review summary: the cause of the right limb occlusion could not be determined form the pre-implant films provided.Angio¿s at implant and earlier follow-up¿s were not available for review and the blood flow dynamics could not be assessed, and the stent graft in-vivo configuration is unknown.A pre-implant 3d-ct film report revealed that the proximal neck diameter ranged from 22 ¿ 21 ¿ 23mm.The distal aorta was 16 x 20mm and extensively calcified, and the iliac arteries were tortuous bilaterally.It is possible that implanting the limbs within the small <(><<)>(> <(>&<)><(><<)>)> calcified distal aorta and the tortuous iliac arteries, may have contributed to the occlusion.It is unclear if oversizing of the 28mm bifurcate into the 22mm neck may have also contributed.The limb occlusion 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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6992612
• Report Number: 2953200-2017-01665
• Device Sequence Number: 11025772
• Product Code: MIH
• UDI-Device Identifier: 00643169467514
• UDI-Public: 00643169467514
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2018
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 10/04/2017; 12/04/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 11/02/2017; 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR