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

Model Number	ENLW1628C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: e nlw1616c93e, serial/lot #: (b)(4), ubd: 22-sep-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of a 6 mm diameter abdominal aortic aneurysm.It was reported that during a follow up ct approximately 9 years post implant, it was noted that there was a separation endoleak between the endurant limbs.An additional limb was implanted on the same day to resolve the separation endoleak.The cause of the event is undetermined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Analysis summary: the reported limb detachment was confirmed; however, the exact cause could not be determined from the limited films returned.The anatomy at implant and earlier post-implant ct¿s were not available for return, and a comprehensive assessment of the patient¿s anatomy could not be performed.Additional films from the detachment event and the intervention were also not provided.It is possible that morphology changes leading to angulation of the limbs may have contributed.The junctional separation appeared to have occurred within the aaa sac; therefore, lack of vessel support may have also been a factor.Insufficient stent graft overlap length at implant may have also contributed to the detachment.Additional information.It was confirmed that the aneurysm size was 60mm.The cause of limb separation as per the physician has been confirmed as likely related to the patient having a tortuous aorta.It also reported that the stent grafts probably weren't overlapped enough at the index procedure which may have contributed to the separation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 9641886
• Report Number: 9612164-2020-00465
• Device Sequence Number: 16794978
• Product Code: MIH
• UDI-Device Identifier: 00613994762177
• UDI-Public: 00613994762177
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 10/10/2012
• Device Model Number: ENLW1628C124E
• Device Catalogue Number: ENLW1628C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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