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

Model Number	ETLW1610C199E
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant stent graft system was implanted in the patient for the endovascular treatment of a 6 cm in diameter abdominal aortic aneurysm.It was reported that the patient was not complaint with follow up appointments.A recent ct revealed that there was a there was good proximal seal all the way up to the lowest renal artery however there is a distal type ib endoleak on the right, ipsilateral side and there was loss of stent graft seal on the left, contralateral side.There was also a3cm saccular aneurysm noted at the distal right common iliac.Per the investigator, the distal type i endoleak and the loss of seal are related to the patient¿s anatomy, dilatation of the iliac limb.No additional clinical sequelae were reported and the patient will be monitored by the physician.It was reported that a procedure was performed to fix at type ib endoleak on the right limb.It was noted that the left limb only had 5 mm of seal before it could be pulled up into the aneurysmal sac also.During the procedure, a left extension limb was implanted without issue.While attempting to deploy the right extension limb, an issue occurred with the full deployment of the stent graft.The physician was about halfway down the screw gear when it was noted that the graft was not coming out of the graft cover.The physician was able to resheath the device and repositioned it.He then attempted to deploy the graft 2 more times and the same thing happened.The physician elected to pull the graft out of the patient to prevent any adverse events.Additional limbs were then successfully used to extend down into the external iliac arteries.It was noted that the event was resolved after this.The cause of the event cannot be determined, as per the physician.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the device was returned in an endovascular return box.The device was returned bloodied with the stent graft partially deployed within the delivery system.Upon inspection of the device, the stent graft had been partially deployed.There were several kinks approximately 100mm, 120mm, 180mm and 190mm from the edge of the graft cover.The external slider was 4mm from the home position.The stent graft was approximately 30mm from the stent stop cup.The tapered tip was curved.The rest of the device was unremarkable.The external slider was rotated and the stent graft moved back with the graft cover until the distal end of the stent graft encountered the stent stop cup.The external slider had been rotated approximately 65mm until the stent graft reached the stent stop cup.The stent graft was then deployed without issue.Once the stent graft was deployed, the edge of the graft cover was flared likely due to the stent graft being partially deployed/attempt at re-sheathing.The stent graft measured approximately 195mm covered length.The complaint was confirmed; there was delay in deployment.Once the distal end of the stent graft was pulled back to the stent stop cup, the device deployed without issue.The root cause of the event could not conclusively be determined; however, the kinks on the graft cover and curvature of the tapered tip are indicative of vessel tortuosity that may have contributed to the event.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: 6970966
• Report Number: 2953200-2017-01620
• Device Sequence Number: 423319
• Product Code: MIH
• UDI-Device Identifier: 00643169467620
• UDI-Public: 00643169467620
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: 03/14/2019
• Device Model Number: ETLW1610C199E
• Device Catalogue Number: ETLW1610C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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: 81 YR