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

Model Number	ETBF3620C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation, conclusion: off-label, unapproved or contraindicated use (aortic neck diameter).
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 5.3 cm abdominal aortic aneurysm.The aortic neck was 3cm in length, and 32-33mm in diameter at the top and 24mm at the base of the neck.Angulation was 60 degrees at the base of the neck.It was reported that, during the initial implant procedure, a type ia endoleak was seen after the main body and a limb were implanted.The physician re-ballooned, added a cuff, and then re-ballooned again.However, the leak was diminished but remained.It was noted that the endoleak was possibly coming from the right side of the neck.The physician was not certain as to the cause of the event; but thought it was most likely a patient anatomy issue due to an angulated and conical neck.No additional clinical sequelae were reported and the patient is being monitored by their physician.
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
Additional information was received as follows: a ct was performed prior to the patient being discharged and it revealed that the endoleak had resolved.
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: 6487969
• Report Number: 2953200-2017-00576
• Device Sequence Number: 1344176
• Product Code: MIH
• UDI-Device Identifier: 00613994991058
• UDI-Public: 00613994991058
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/21/2017

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: 07/19/2018
• Device Model Number: ETBF3620C145E
• Device Catalogue Number: ETBF3620C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided; 04/21/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 05/16/2017; 10/02/2017
• 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: 74 YR