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

Model Number	ETUF3214C102E
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
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 68mm abdominal aortic aneurysm.It was reported that during the index procedure, while advancing the delivery system, the physician had some resistance.After ballooning the external iliac where a stent was in place and dilating with 16 and 20fr dilators the physician placed a 20 french sheath into the distal aorta and placed the aui through it.After imaging, the stent graft was deployed and it was attempted to release the supra renal stents but they didn¿t open even after use of a balloon in between the bare metal.It was decided to explant and convert to an open procedure.On removal of the stent graft and delivery system it was identified that the stent from the iliac had displaced.As per the physician, the cause of the event was related to the displaced iliac stent preventing the supra renal stents from opening.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film analysis evaluation: two (2) still angiograms during implant were returned.Only the proximal 3cm's an endurant aui was observed; the iliac arteries were not visible.The aui was seen partially deployed in the patient; however, the suprarenal stents had not deployed.In one image the tip capture appeared to have not been advanced as the spindle was not exposed, and the other image revealed that the tip was advanced several mm¿s exposing the spindle.In both images all of the suprarenal stent apices were still attached to the spindle and had not deployed.No obvious delivery system or stent graft issues were observed and the cause of the non-deployment of the suprarenal stents could not be determined.Five (5) still photographs and a 13 second video of the stent graft and delivery system immediately after removal from the patient during open repair were also returned.The images revealed that none of the suprarenal stents had deployed.The tip/sleeve was positioned ~10mm above the level of the spindle and all of the suprarenal stent apices were tightly constrained around the delivery system lumen; just above the level of the spindle.There appeared to be a large amount of patient tissue and a metallic object (likely the reported iliac stent) trapped within the constrained stents.No other obvious stent graft or delivery system issues were observed.The inability to release the suprarenal stents reported during implant was confirmed.The delivery system tip capture mechanism appeared to have been caught on an iliac stent that was reported to have been previously implanted, and had pulled the vessel/ stent up with the d-s prior to deployment of the aui.However, the exact cause of the d-s displacing and capturing the stent could not be determined from the limited films provided.Ct¿s prior to implant were not provided and the anatomy at implant including morphology of the access vessels and stent assessment is unknown, and additional images during occurrence of the event were not provided.It is possible that the cause was due to patient anatomy and/or a procedural user issue.A device issue cannot be ruled out as a potential cause.However, the delivery system and stent graft were not returned and a product investigation could not be performed.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: 8222490
• Report Number: 2953200-2019-00032
• Device Sequence Number: 277167
• Product Code: MIH
• UDI-Device Identifier: 00643169232617
• UDI-Public: 00643169232617
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 10/08/2020
• Device Model Number: ETUF3214C102E
• Device Catalogue Number: ETUF3214C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2018
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/01/2019
• 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: 87 YR