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

Model Number	ETLW1613C156E
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
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 a 65.7mm diameter abdominal aortic aneurysm.It was reported that during the index procedure, the stent graft was difficult to track up the right femoral.Upon inspection the physician noticed the blue and grey handle were separated by roughly 2mm.It was reported that the physician removed the device to inspect the stent graft cover and it was found that the stent cover had become bent.The physician discontinued with that delivery device and successfully completed the procedure with a newly opened device.It was noted that no damage was noted to the outer packaging of the device.Per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported difficulties tracking the limb up the right femoral, and the reported 2mm separation between the blue and grey handle of the delivery system kinked graft cover, could not be determined from the pre-implant films provided.Images during implant were not available for review and the reported event could not be assessed.Post-implant ct¿s were also not returned.A pre-implant 3d-ct film report noted that the distal aorta was 22mm in diameter and calcified, and the common iliac arteries were moderately tortuous and calcified bilaterally.The right common iliac artery ranged in diameter from 12 ¿ 13mm, and the left common iliac artery ranged in diameter from 17 ¿ 12mm.The access vessel diameter¿s were not measured (noted as ¿ok); however, some anterior calcification was noted at access.Other than the calcified and moderately tortuous vessels, analysis of the returned pre-implant films did not reveal any anatomical characteristics that could explain the reported event.A device issue cannot be ruled out as a potential cause.The delivery system is expected to be returned for analysis and the results will be summarized in a separate report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary the device was slightly curved.Kinks were observed on the graft cover immediately distal to the stent stop.Scratches were visible along the length of the taper tip.The tip of the graft cover was damaged with a tear, material deformation and scratches observed.The reported separation between the grey front grip and the blue external slider was not evident on return of the device.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: 7884524
• Report Number: 2953200-2018-01306
• Device Sequence Number: 10820063
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2018

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: 05/28/2020
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 09/20/2018; 12/03/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/11/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR