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

Model Number ESBF2514C103EJ

Device Problems Leak/Splash (1354); Difficult To Position (1467); Malposition of Device (2616)

Patient Problems Occlusion (1984); Injury (2348)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii s stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm and right common iliac artery aneurysm.It was reported that during the index procedure positioning of the endurant stent graft was difficult and after deployment in the tortuous anatomy, the angiogram showed a type ia endoleak and that the left renal artery was blocked by the stent graft.It was reported the cause of the type ia endoleak and left renal artery blockage is unknown.Intervention was performed with the implantation of a non mdt stent graft over the suprarenal stents but the endoleak persisted.A snorkel was implanted in the left renal artery to restore blood flow.Due to the length of procedure the physician didn't proceed with trying to cannulate the right renal artery and final angiogram showed a patent left renal artery.An endoleak was observed proximally - possible type ia or type iv.No additional clinical sequelae were reported and the patient is being monitored.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7517750
• MDR Text Key: 108355388
• Report Number: 2953200-2018-00708
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2019
• Device Model Number: ESBF2514C103EJ
• Device Catalogue Number: ESBF2514C103EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/16/2018
• Date Device Manufactured: 10/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR