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

Model Number	ETLW1613C156E
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
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 iis bifurcate stent graft system was implanted in the endovascular treatment of a 53mm abdominal aortic aneurysm.The aortic neck was reported between 4mm and 10mm.It was reported during the index procedure, the main body stent graft was implanted at the level of the renal arteries as planned.A marker pigtail was placed at the level of the flow divider contrast injecting was performed.The endurant limb etlw1613c156e, was inserted and put into position.The device was then pushed forward inadvertently and deployed inaccurately.It was reportedly too late to push the limb down to the correct position.The ipsilateral limb then implanted correctly as planned.The entire stent graft system was then ballooned with a reliant balloon.The final angiogram then showed a slight ia endoleak.It was reported that an aortic cuff could not be implanted as treatment due to the inaccurately placed contralateral limb.Six endoanchors were then implanted proximally on the enduant bifurcate device.This resolved the endoleak.The final angiogram demonstrated both patent renals arteries no type ia or ib endoleaks and equal-patent limbs bilaterally.As per the physician the cause of the end was the inaccurately placed limb.No additional clinical sequalae were provided and the patient is fine.

• 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 ; IE
• MDR Report Key: 10194124
• Report Number: 9612164-2020-02315
• Device Sequence Number: 3081877
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: 04/07/2022
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/25/2020
• 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