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

Model Number	ETBF2516C145E
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Renal Failure (2041); Injury (2348); Respiratory Failure (2484); Blood Loss (2597)
Date of Event	03/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: etlw1616c124e, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (b)(4); product id: sa-85, serial/lot #: 49245, ubd: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii aortic cuff stent graft and aptus endoanchors were implanted in a patient for the endovascular treatment of a type ia endoleak in a previously implanted endurant ii stent graft system implanted 10 months previously.It was reported approximately 3 months post the implantation of the enurant cuff and endoanchors the patient presented emergently with abdominal pain and a proximal type i endoleak.The physician elected to surgical convert the patient to a conventional graft and explant the evar devices and endoanchors.It was reported during the reintervention procedure the patient suffered intraoperative splenic bleeding and hypotension.The patient was diagnosed with thrombocytopenia marked by abnormal haematology values from the associated blood loss during the re-intervention surgery which was reported as 3.5l.A splenectomy was performed and the patient was treated with medication including several blood and platelet infusions.It was further reported the patient experienced and acute kidney injury most likely contrast induced marked with oliguria and diagnosed with a uti.This was treated with medication and prolonged hospitalisation.The patient also required mechanical ventilation for respiratory failure post-op.Per the investigator the events were all related to the reintervention procedure.No additional sequale were reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information received: the date the type ia endoleak was first noted has been updated.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: 7761131
• Report Number: 2953200-2018-01145
• Device Sequence Number: 1793307
• Product Code: MIH
• UDI-Device Identifier: 00613994991263
• UDI-Public: 00613994991263
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/22/2018

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: 01/29/2016
• Device Model Number: ETBF2516C145E
• Device Catalogue Number: ETBF2516C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/15/2018; 11/19/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/24/2018; 11/22/2018
• 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: 88 YR
• Patient Weight: 145