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

Model Number	ETBF2313C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: (catalog number etlw1613c124e, serial number (b)(4), use by date 2017-11-01 and upn# (b)(4) for all additional plis).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 inserted in a patient for the endovascular treatment of a 51 mm diameter abdominal aortic aneurysm.Currently the right iliac is 14.8 mm ¿ 10.3 mm from proximal to distal.The left iliac is 15.5 mm, 13, 10.8 mm from proximal to distal.It was reported that a follow-up ct was done and showed that the aneurysm has grown from 5.1 cm to 6.1 cm in 18 months.Neither limb had wall apposition in the iliac arteries, and the iliacs had dilated larger than the 13 mm diameter limbs.There was a 30-35 mm gap from edge of the limbs to the hypogastric artery on both sides.The physician elected to implant endurant stent graft limbs bilaterally [16x13x93].The endoleak appeared to be resolved.Per the physician the cause of the event was anatomy related (the limbs pulled up as the aneurysm sac grew and the iliacs dilated).No additional clinical sequelae were reported and the patient is fine.

• 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: 6796584
• Report Number: 2953200-2017-01299
• Device Sequence Number: 149635
• Product Code: MIH
• UDI-Device Identifier: 00613994991188
• UDI-Public: 00613994991188
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 07/22/2017

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: 10/27/2017
• Device Model Number: ETBF2313C166E
• Device Catalogue Number: ETBF2313C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2017
• Initial Report FDA Received Date: 08/16/2017
• 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: 79 YR