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

Model Number	ETBF3616C145E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	10/14/2019
Type of Reportable Event	Death
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.It was reported that the patient presented emergently approximately four years later with a contained aneurysm rupture.A ct scan showed a type ia endoleak.A non-mdt (gore) cuff was implanted to address the endoleak, along with endoanchors.It was reported that the physician decided to decompress the abdominal compartment, and in doing so the retroperitoneal cavity gave way.After much effort to save the patient it was reported that the patient died.It was reported that a possible type iiia endoleak was noted after opening the aneurysm sac peri-mortem.As per the physician, the cause of the type ia endoleak was either stent graft migration or aortic dilation.No additional clinical sequelae were reported and the patient has expired.
Additional Manufacturer Narrative
Additional information received: per the physician a type iii endoleak is not definitely confirmed and commented that due to poor visibility a type iiia was suspected.Some blood pull between the new cuff and the original device was suspected but this was not confirmed.Angiographically everything looked good but then the sac ruptured which may have caused a loss of integrity of the aneurysm sac and as a result everything moved down.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 9197050
• Report Number: 9612164-2019-04383
• Device Sequence Number: 3058103
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2019

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: 02/14/2016
• Device Model Number: ETBF3616C145E
• Device Catalogue Number: ETBF3616C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 11/01/2019; 11/26/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/25/2019; 12/11/2019
• 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: Death; Required Intervention
• Patient Age: 84 YR