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

Model Number	ETLW1628C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: e tcf3232c49e, serial/lot #: (b)(4), ubd: 05-dec-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft cuff and limb were implanted in a patient for the endovascular treatment of an unknown endoleak.The patient had an anuerx stent graft system previously implanted, on an unknown date approximately 8 years earlier.It was reported that the patient presented with an unknown endoleak approximately 8 years post implant of the aneurx stent graft system.Two weeks later, the physician did multiple injections, however was not able to reproduce the endoleak.The physician stated that they saw a defect in the right limb of the aneurx stent graft.The etlw1628c124e endurant limb was then implanted as treatment.The endoleak was not resolved.As per the physician, the cause of the event could not be confirmed.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary the endoleak was confirmed; however, the exact cause and type of endoleak could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not provided.Limited ct¿s returned from 11 years post-implant confirmed an endoleak most likely coming from the right limb of the aneurx.Near the endoleak the limb was acutely angulated ~90 deg near to where it exited the gate, and there was potentially a fractured stent strut(s) observed at the inner curvature of this acute bend.It appears most likely that this was a type iiib fabric endoleak which was possibly caused by limb angulation, leading to the strut fracture, which resulted in abrasion of the fabric.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: 9449483
• Report Number: 9612164-2019-05092
• Device Sequence Number: 3080554
• Product Code: MIH
• UDI-Device Identifier: 00643169467453
• UDI-Public: 00643169467453
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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: 09/23/2021
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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: 69 YR