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

Model Number	ETBF3216C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2021
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 the patient for the endovascular treatment of a 67 mm abdominal aortic aneurysm.It was reported that a ct was performed approximately 6 years post procedure, where a potential type 1b endoleak was observed.After review of the ct, the 16x20x93 on the ipsilateral (right side) was noted to have contrast outside of limb and flow noted in the aneurysm sac.Physician then decided to take patient to surgery for further evaluation and intervention.Upon first angiogram, distal portion of 16x20x93 noted in proximal common iliac and contrast flowing back into sac.Additionally, a small type 1a endoleak was noted at the neck below the renals artery, contrast blushing outside of graft into sac.Patient did not present with any signs or symptoms of a rupture.It was stated that the a 32x32x49 abdominal cuff was placed directly below the renals artery.The 16 x 20 x 93 limb on the ipsilateral side was extended with a 16 x 10 x 124 into the external iliac.Due to the tortuosity, a 13 x 10 non-medtronic device was extended out of the 16 x 10 x 124.Per angiogram, the type 1a and type 1b endoleak were resolved.As per the physician the cause of the event can not be determined.No additional clinical sequalae were reported and the patient is fine.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12174399
• Report Number: 9612164-2021-02747
• Device Sequence Number: 887481
• Product Code: MIH
• UDI-Device Identifier: 00613994990990
• UDI-Public: 00613994990990
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 06/28/2017
• Device Model Number: ETBF3216C166E
• Device Catalogue Number: ETBF3216C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2021
• Initial Report FDA Received Date: 07/15/2021
• 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
• Patient Weight: 83