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

Model Number	ETUF3614C102E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
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 anuerx stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.An endurant ii cuff was also implanted approximately 6 years post the index procedure for a suspected stent graft migration and type ia endoleak.It was reported that the patient presented emergently approximately 12 years post the index procedure with abdominal pain.A ct showed a type iii endoleak between the cuff and bifurcated stent graft.The physician reported the cause of the event to be related to patient anatomy and reported there was a morphology change due to angulation between the neck and existing bifurcated stent graft.It was reported that the current diameter of the aorta at the renal artery was 35 mm, the current length of the proximal aortic neck was 5mm, and the degree of angulation was 50.The patient was treated with an endurant ii abdominal tube, an endurant ii limb extension, seven endoanchors and a reliant balloon.A non-mdt plug was also implanted in the patient and a fem-fem bypass carried out.Either a type ia or type ii endoleak was noted on the final angiogram.The event was reported to have been resolved.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the events could not be determined from the limited films provided.The anatomy at implant is unknown, and earlier post-implant films were not available for review.Two post-implant ct¿s slices and a single still angiogram from an unspecified study date were returned.The films confirmed that the aneurx bifurcate had migrated into the sac and was positioned >8cm below the renal arteries.An endurant aortic extension was seen implanted just below the renal arteries, and there was a 1 ¿ 2 cm gap between the distal end of the extension and the bifurcate with contrast seen at the separation from a type iiia junctional endoleak.Migration of the 28mm diameter aneurx bifurcate appeared to have been caused by disease progression with dilatation of the neck diameter to ~35mm, as well as possible aneurysm morphology changes as seen with the current severe neck and iliac limb angulation.The exact cause of the component detachment leading to the type iiib endoleak is unknown.Films just prior to the cuff implant were not available and the amount of initial device overlap is unknown.It is likely that morphology changes as well as severe diameter oversizing between the 36mm aortic extension and bifurcate may have also contributed to the type iii junctional separation within the unsupported aneurysm sac.The exact cause of the reported endoleak noted on the final angiogram after implant of an abdominal tube, limb extension, and multiple endoanchors also could not be determined.Films were not available.It is possible that implanting within the large diameter (35mm) and short <10mm) length neck which was also angulated may have all contributed to a potential proximal type i endoleak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7568396
• Report Number: 2953200-2018-00803
• Device Sequence Number: 11257609
• Product Code: MIH
• UDI-Device Identifier: 00643169232631
• UDI-Public: 00643169232631
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

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: 11/22/2019
• Device Model Number: ETUF3614C102E
• Device Catalogue Number: ETUF3614C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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: Hospitalization
• Patient Age: 76 YR