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

Model Number	ETEW2020C82E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 of a 4.0 cm abdominal aortic aneurysm.It was reported that, during the implant procedure, the graft size (23 x 23 x 70) that the physician wanted to use was unavailable.The physician selected a different length graft (20 x 20 x 82), which proved to be too long and resulted in occlusion of the left common iliac artery.A femoral-femoral bypass was preformed and the event resolved.The physician stated that the cause of the event was due to device oversizing.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 EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6530235
• Report Number: 2953200-2017-00702
• Device Sequence Number: 896057
• Product Code: MIH
• UDI-Device Identifier: 00613994991393
• UDI-Public: 00613994991393
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/06/2017

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: 08/23/2018
• Device Model Number: ETEW2020C82E
• Device Catalogue Number: ETEW2020C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 83 YR