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

Model Number	ETBF2816C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: the reported endoleak was confirmed; however, the exact cause and endoleak type could not be determined from the films provided.The anatomy at implant is unknown, earlier post-implant films were not provided for comparison, and films during the planned angiograms were not available for review.Contrast was seen along the outside the bifurcate along the calcified proximal 15mm of the neck; however, the distal neck appeared sealed 20mm below the top of the bifurcate and no clear type ia could be confirmed.There was likely disease progression; neck dilatation.Contrast seen along the distal end of both iliac limbs with no type ib endoleak also appeared to have been caused by disease progression.Another area of contrast was seen coming from bifurcate ipsi limb at the level of the flow divider, near an area of significant calcification.The endoleak appears most likely to have been a type iiib fabric endoleak caused by fabric abrasion.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).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.
Event or Problem Description
An endurant ii bifurcate stent graft was implanted in the endovascular treatment of a unknown size aortic abdominal aneurysm it was noted that when the patient returned for follow-up seven years later, the patient had an unknown endoleak observed on ct thought to be a possible type i and/or type iii endoleak.No cause of the event has been reported.No additional clinical sequalae were reported and the patient will be monitored.

• 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: 9726397
• Report Number: 9612164-2020-00786
• Device Sequence Number: 19565140
• Product Code: MIH
• UDI-Device Identifier: 00613994991133
• UDI-Public: 00613994991133
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2014
• Device Model Number: ETBF2816C166E
• Device Catalogue Number: ETBF2816C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR