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

Model Number	ETLW1624C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: etlw1616c93e, serial/lot #: (b)(4)., ubd: 04-dec-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascaular treatment of an 110mm ruptured abdominal aortic aneurysm.It was reported that later that evening the patient presented emergently with a re-ruptured aneurysm and had a drop in blood pressure as a result.Intervention was performed and a aui device was implanted and a fem/fem bypass was performed and the event was reported to be resolved.As per the physician the cause of the event was limb overlap.It was confirmed the separation occurred between the stent graft limbs etlw1624c124 and etlw1615c93 and the bifurcated stent graft was not involved.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Product analysis conclusion: the reported type iiia separation endoleak could not be confirmed on the films provided; therefore the cause of the event could not be determined.Lack of returned angiography images showing the endoleak, which may have included possible endoleak interrogation, did not permit a more comprehensive analysis of the endoleak source/cause.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.The overlap between the bifurcate and the ipsilateral limb was unable to be determined from the films provided, whereas overlap between the bifurcate and the contralateral limb appeared adequate.The films did not appear to show further limbs implanted as reported from the site.Analysis of the returned images did not reveal any obvious out of specification stent graft integrity issues.Additional information received.It was reported the rupture was caused by the type iiia 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.

• 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: 10095121
• Report Number: 9612164-2020-01999
• Device Sequence Number: 14233692
• Product Code: MIH
• UDI-Device Identifier: 00643169467507
• UDI-Public: 00643169467507
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2020

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: 02/16/2022
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 06/19/2020; 08/10/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/13/2020; 08/10/2020
• 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: 72 YR