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

Model Number	ETBF2313C145E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 70mm in diameter abdominal aortic aneurysm with a pre-operative rupture.It was reported that a follow up ct scan observed limb compression against the normal distal aorta.The physician performed an intervention and implanted a balloon expandable stent and the event was resolved.The physician then elected to implant additional balloon expandable stents bilaterally as a prophylactic.Per the physician, the cause of the event was due to the patient anatomy.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6283960
• Report Number: 2953200-2017-00122
• Device Sequence Number: 13611975
• Product Code: MIH
• UDI-Device Identifier: 00613994991171
• UDI-Public: 00613994991171
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/17/2017

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: 09/08/2018
• Device Model Number: ETBF2313C145E
• Device Catalogue Number: ETBF2313C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 87 YR