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

Model Number	ETBF2813C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: etlw1613c124e, serial/lot #: (b)(4), ubd: 01-jun-2014, udi#: (b)(4).Evaluation summary: the reported proximal type i endoleak was confirmed; however, the exact cause of the type i endoleak and aaa expansion could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not provided for comparison.Films after intervention with an aortic cuff and additional iliac limbs, which reportedly resolved the endoleak, were also not available for review.It is possible that disease progression (neck dilatation) led to the inadequate proximal seal.It is also possible that the multiple coils seen within the distal aaa sac on the posterior wall, which appeared to be in contact with the posterior side of the contra limb near an area of sac contrast, may have also contributed to the reported aaa increase.Although a distal type i endoleak cannot be ruled out, this distal sac contrast appears most likely to have been from a contra limb type iiib fabric endoleak caused by abrasion from the coils.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 55mm abdominal aortic aneurysm.It was reported approximately 2 years post the index procedure, follow up ct revealed a type ia endoleak as well as probable bilateral type ib endoleaks with aaa expansion.Intervention was completed on by implanting a cuff and 9 endoanchors proximally and extending both limbs.An angiogram was completed demonstrating complete resolution of all endoleaks.Per the physician the cause of the ia endoleak was likely due to aortic dilatation which caused the aaa to dilate as well as the iliacs until the limbs lost seal.No additional clinical sequelae were reported and the patient is fine.

• 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: 8816697
• Report Number: 9612164-2019-03018
• Device Sequence Number: 11540563
• Product Code: MIH
• UDI-Device Identifier: 00613994991300
• UDI-Public: 00613994991300
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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: 05/09/2014
• Device Model Number: ETBF2813C166E
• Device Catalogue Number: ETBF2813C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/23/2019
• 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: 84 YR