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

Model Number	ETLW1616C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
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 55 mm abdominal aortic aneurysm on (b)(6) 2013.It was reported that when the patient returned for follow up approximately 5 years post the index procedure it was noted that the patient possibly had a type iii endoleak associated with a graft tear or hole in the area of the main trunk of the bifurcated stent graft system.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Section information references the main component of the system.Other relevant device(s) are: product id: etbf3216c145e, serial/lot#: unknown, ubd: unknown, udi#:unknown film analysis summary: the reported fabric hole was confirmed; however, the exact cause could not be determined from the limited films provided.Pre-implant films were not available, and post-implant ct¿s were not provided and a more comprehensive assessment of the patient¿s anatomy and stent graft in-vivo configuration could not be performed.In addition, recent ct¿s and additional contrast angiograms during the catheter interrogation which may have revealed an endoleak were not available for review.Three (3) still angiograms during an intervention on an unknown study date were returned.The films were non-contrast with no visible scale; therefore, no assessment of any endoleak or stent graft/vessel patency could be performed, the location of the device relative to the visceral vessels is unknown, and no stent graft or vessel measurements could be performed.The films revealed that an endurant stent graft system had been implanted into the patient.Multiple coils were also seen having previously been placed near the ipsi limb at the level of the gate ring.A catheter of unknown size was seen placed up the right/ipsi limb and into the proximal margin of the bifurcate aortic body, and was directed toward the lateral-right wall of the bifurcate mid-body near the stent ring #3; the catheter/wire appeared to have passed through the fabric and into the aaa sac indicating a likely fabric hole.The cause of the hole could not be determined.Analysis of the returned films did not reveal any stent graft characteristics that could explain the observed event.No obvious stent graft issues were seen near the vicinity of this likely fabric hole, and the bifurcate aortic body was essentially straight along its length with no observed stent ring overlapping.It is possible that external abrasion, possibly from calcification, may have contributed to a fabric tear.No images were seen during contrast injection from above the level of the renals prior to the catheter interrogation; therefore, the assessment of any potential type iiib fabric endoleak which may have occurred via this likely fabric hole could not be performed.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: 8154341
• Report Number: 2953200-2018-01676
• Device Sequence Number: 10825948
• Product Code: MIH
• UDI-Device Identifier: 00613994991591
• UDI-Public: 00613994991591
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 09/26/2015
• Device Model Number: ETLW1616C124E
• Device Catalogue Number: ETLW1616C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1