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

Model Number	ETBF3216C166E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/20/2019
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 an abdominal aortic aneurysm on (b)(6) 2014.It was reported that ct five years post the index procedure showed a type ii endoleak (that was possibly a type ia).It was reported that there was a lumbar artery filling the aneurysm sac and possibly a type ia endoleak from neck dilation, and possible migration.An aortogram approximately one month later showed a type ii endoleak and that the stent graft was 10mm from the level of the lowest renal artery.There was no apparent type ia endoleak.It was reported that the stent graft had migrated 3-4 mm but it not the cause of the endoleak.The endoleak was confirmed to be a type ii caused by a lumbar artery.The type ii endoleak was treated by carrying out coiling.An endurant ii stent graft cuff was then implanted up to the level to the lowest renal and 10 endoanchors were also placed to treat the migration.An aortogram confirmed the type ii endoleak had resolved and there was no type ia endoleak noted.The cause of the migration is unknown.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: it was confirmed by the physician that the cause of the migration is not known.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9557193
• Report Number: 9612164-2020-00109
• Device Sequence Number: 2408640
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 11/13/2016
• Device Model Number: ETBF3216C166E
• Device Catalogue Number: ETBF3216C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/18/2020
• 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: 85 YR