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

Model Number	ENLW1628C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: enlw1628c93e, serial/lot #: (b)(4), ubd: 22-nov-2012, udi #: (b)(4); product id: enew2828c82e, serial/lot #: (b)(4), ubd: 22-nov-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 an abdominal aortic aneurysm on and an additional endurant ii stent graft limb etew2828c82e was implanted as a secondary limb extension four years and nine months later to treat a type ib endoleak.It was reported that follow up ct on seven years and nine years later showed a distal type ib endoleak with the right common iliac measuring 31 mm.A secondary procedure was carried out and the right internal iliac artery was coiled and a stent graft limb etlw1610c199e placed to the external iliac artery.Final angiogram showed no evidence of a endoleak.As per the physician, the cause of the endoleak was disease progression of the right common iliac artery.No additional clinical sequelae were reported and the patient is fine.

• 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: 9391460
• Report Number: 9612164-2019-04945
• Device Sequence Number: 2490723
• Product Code: MIH
• UDI-Device Identifier: 00613994761873
• UDI-Public: 00613994761873
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 11/29/2019

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: 09/20/2012
• Device Model Number: ENLW1628C82E
• Device Catalogue Number: ENLW1628C82E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/29/2019
• 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: 69 YR