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

Model Number	ETBF2816C124E
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/20/2020
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 bifurcate stent graft system was implanted in a patient for the endovascular treatment of an 65mm abdominal aortic aneurysm.It was reported that during the index procedure, etbf2816c124e was implanted without issue.3mensio centerline work-up was performed and it was indicated a lowest 3rd renal to aortic bifurcation measurement of 81mm.It was reported that the gate was released in an anatomical position and the graft deployment complete and delivery system removal successfully.It was reported that the physician was not able to cannulate the contralateral gate.Attempts were performed to advance catheter, wire, snare and approach techniques without success.It was reported that the physician noted while attempting to access that the gate opening was close to the posterior portion of the aneurysm.It was reported that the physician then decided to use etuf2814c102e, which was successfully placed to the fem-fem and left iliac plug.As per the physician, cause of the event was anatomy.No additional clinical sequelae were reported and the patient will be monitored.

• Brand Name: ENDURANT II BIFURCATED 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: 10395213
• Report Number: 9612164-2020-02966
• Device Sequence Number: 3577934
• Product Code: MIH
• UDI-Device Identifier: 00613994991317
• UDI-Public: 00613994991317
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/12/2020

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: 05/12/2022
• Device Model Number: ETBF2816C124E
• Device Catalogue Number: ETBF2816C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/12/2020
• 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
• Patient Age: 86 YR
• Patient Weight: 100