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

Model Number	ENBF2820C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
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
Films review summary: the exact cause of the events could not be determined from the films provided.Pre-implant anatomy is unknown, and earlier follow-up films were not available as the patient was not compliant with follow-up¿s.Ct¿s from 6-½ years post-implant revealed that there was a distal type i endoleak from the right/ipsilateral limb; the distal end of the right limb appeared to have pulled out of the right common iliac and was floating within the distal sac with a type ib endoleak.There was also dilatation of the rcia diameter to ~26mm.The contra limb on the left side was noted to have <(><<)>(><(><<)><(><<)>)>10mm of remaining distal seal length.However, no clear distal type i was seen on the left side.It is possible that the cause of the inadequate bilateral distal seals was due to disease progression (vessel dilatation) and aneurysm morphology changes.The cause of the deployment difficulties reported during intervention for repair of the distal type i from the right limb could not be determined.Pending device return and rgi analysis which will be in a separate report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 6970963
• Report Number: 2953200-2017-01618
• Device Sequence Number: 488727
• Product Code: MIH
• UDI-Device Identifier: 00613994762467
• UDI-Public: 00613994762467
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 01/24/2013
• Device Model Number: ENBF2820C145E
• Device Catalogue Number: ENBF2820C145E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/29/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/17/2017
• 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