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

Model Number	ETEW2828C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: review of a pre-implant ct/3d film report ((b)(6) 2019 study) revealed that the patient had a 37 x 29mm maximum the reported endoleak was confirmed; however, the exact endoleak type/cause could not be determined from the returned film reports.Complete ct¿s were not available for review and a complete assessment of the patient¿s anatomy could not be performed.Images during implant were also not available, and the original position and orientation of the implanted device could not be determined.Although a type iiib fabric cannot be ruled out, this appeared most likely to have been a proximal type i endoleak.Treating the patient¿s pau with a limb instead of a bifurcate or cuff with suprarenal fixation, may have been a contributing factor.The current proximal neck seal zone length of ~10mm most likely has resulted in a marginal seal along the proximal ¿open-web¿ configuration of the limb.It is also possible that the limb may have migrated and/or the pau has increased in length due to disease progression.The observed increase in neck angulation indicates potential disease progression which may have also contributed to the endoleak.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft limb was implanted in a patient for the endovascular treatment of a 37mm abdominal aortic aneurysm.It was reported that approximately 4 months 10 days post implant, a type ia endoleak was noted on the patient's cta.As per the physician, the cause of the event is due to disease progression.No additional clinical sequelae were reported and the patient is being monitored.

• 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: 9150084
• Report Number: 9612164-2019-04206
• Device Sequence Number: 16905679
• Product Code: MIH
• UDI-Device Identifier: 00613994991416
• UDI-Public: 00613994991416
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 01/02/2021
• Device Model Number: ETEW2828C82E
• Device Catalogue Number: ETEW2828C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR