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

Model Number	ENLW1613C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that a follow up ct scan showed an enlarging aneurysm sac.The patient was brought to the or for endoleak repair.Angiogram of the right endograft limb demonstrated a type iii endoleak.The endoleak was repaired with a 16x16x135 limb from another manufacture.Final angiogram showed the endoleak has been resolved.The physician stated that the cause of the event was anatomy related.The ct showed a large piece of calcium near the fabric hole.The physician stated that the 6 years of rubbing on the calcium probably caused the fabric tear.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film review the exact cause of the type iii fabric endoleak leading to the aaa expansion could not be determined from the films provided.However, this appears most likely to have been anatomy related due to calcification abrading the fabric of the ipsilateral limb.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: 6829746
• Report Number: 2953200-2017-01358
• Device Sequence Number: 1522399
• Product Code: MIH
• UDI-Device Identifier: 00613994761972
• UDI-Public: 00613994761972
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/30/2017

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: 09/19/2012
• Device Model Number: ENLW1613C124E
• Device Catalogue Number: ENLW1613C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 09/22/2017
• 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: 80 YR