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

Model Number	ETBF2516C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/09/2019
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 a 65mm abdominal aortic aneurysm.It was reported approximately 5 years post the index procedure, the patient presented to hospital symptomatic but stable.Ultrasound identified a type iii endoleak near the body of the graft.Due to coils previously placed in the aneurysm sac, the ct scan was not as definitive for endoleak determination.An angiogram was completed confirming a type iii endoleak above the flow divider in the main body of the graft.Endoanchors were placed in the original graft to fixate it to the wall and also prophylactically for a type ia if it was there, but not evident.An endurant aui was then implanted (etuf2814c102e) at the level of the renals and extended to the left hypogastric with a (etlw1620c124e) gaining a centimeter of seal on the left with the additional limb.The right limb was embolized and a fem-fem bypass was done.Per the physician the cause of the type iii endoleak was due to undersizing.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
The reported endoleak was confirmed; however, the exact type and cause could not be determined from the limited still films provided.Pre-implant films were not available and a comprehensive assessment of the patient¿s anatomy could not be determined.Post-implant ct¿s were not provided for assessment of the stent graft in-vivo configuration, and lack of additional angiograms including cine¿s during contrast injection did not allow for a more comprehensive determination of the endoleak source/cause.Analysis of the two returned still angiograms did not reveal any out of specification stent graft integrity issues.The endoleak appears most likely to have been a type iiib fabric endoleak; however, the cause is unknown.Fabric wear due to external abrasion from aortic calcification or from adjacent stent(s) abrading the bifurcate near the level of the flow divider are a potential root cause(s).Abrasion from the coils seen near the endoleak location also cannot be ruled out.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9341331
• Report Number: 9612164-2019-04803
• Device Sequence Number: 2183240
• Product Code: MIH
• UDI-Device Identifier: 00613994991270
• UDI-Public: 00613994991270
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/11/2019

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: 04/22/2015
• Device Model Number: ETBF2516C166E
• Device Catalogue Number: ETBF2516C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 11/10/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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: 85 YR