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

Model Number	ESBF3214C103E
Medical Device Problem Codes	Leak/Splash (1354); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2021
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 iis bifurcate stent graft system was implanted in the patient for the emergent endovascular treatment of a 67mm ruptured abdominal aortic aneurysm.It was reported the patient was becoming unstable when arriving to theatre, the physician managed to seal the aneurysm.It was reported that as per management of a rupture protocol, the main body bifurcation was moved in the 12mm conical neck and only half of that seal length was obtained sequentially producing a small type ia endoleak.An endurant cuff along with 6 heli-fx endoanchors were then implanted to treat the ia endoleak.It was reported the patient expired early the following day.Per the physician the cause of the event was was considered that the patient had arrived too late into hospital and that the coagulation cascade was too far along, when an exploratory laparotomy was performed for decompression of the abdomen, a severe diseased liver was also observed.It was reported the physician was happy with the performance of the stent grafts but it was noted that these types of patients usually don't recover from this type of insult.No additional clinical sequalae were reported and the patient has expired.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11715752
• Report Number: 9612164-2021-01627
• Device Sequence Number: 3309106
• Product Code: MIH
• UDI-Device Identifier: 00763000306342
• UDI-Public: 00763000306342
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/23/2021

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: 11/26/2022
• Device Model Number: ESBF3214C103E
• Device Catalogue Number: ESBF3214C103E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/23/2021
• 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: Death; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 117