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

Model Number	ETLW1624C82E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
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 system was implanted in a patient for the endovascular treatment of an unknown sized dissection.It was reported that the patient was admitted to emergency room (er) with a rupture approximately 4 years post the index procedure confirmed on ct.The patient had developed a type ib endoleak from the right common iliac artery, the patients vitals were reportedly stable.The patient received treatment with two extension limbs placed in the right common iliac artery and the endoleak resolved.As per the physician, the cause of the event could not be determined but it is likely due to the type ib that was observed during the intervention.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information was received for this case: the physician commented that the patient ''did great'' and was discharged without further incident.Per the physician the cause of the rupture was anatomy related and not device related.Films review summary: a single still angiogram during an intervention (unknown study date) was returned.Multiple stent grafts were seen overlapping within the right common iliac artery.The proximal extent of the angio showed the limbs extending from the contralateral gate ring, and the distal extent showed the distal limb positioned just proximal to (most likely) the right internal iliac artery.Contrast injection within the right limbs did not show any endoleak within the aaa or any right iliac artery perforation.The stent grafts were patent, essentially straight, and no stent graft kinks or compression was observed.Assessment of the left limbs could not be performed as contrast was not injected into the left limbs.The exact cause of the type ib endoleak leading to the rupture could not be determined from the single film provided.Films showing the event were not returned.Since additional limbs were implanted to extend distally into the rcia, it is possible that the distal seal was insufficient in length and/or radial apposition.Disease progression may have been a contributing factor.If information is provided in the future, a supplemental report will be issued.

• 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: 7317629
• Report Number: 2953200-2018-00331
• Device Sequence Number: 18869831
• Product Code: MIH
• UDI-Device Identifier: 00613994991676
• UDI-Public: 00613994991676
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: 09/24/2015
• Device Model Number: ETLW1624C82E
• Device Catalogue Number: ETLW1624C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 04/05/2018
• 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: 88 YR