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

Model Number ETBF3216C145EJ

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Renal Failure (2041); Reaction (2414)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

Off-label, unapproved or contraindicated use arteriosclerosis obliterans, total occlusion.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 45.5 cm abdominal aortic aneurysm, arteriosclerosis obliterans, and chronic total occlusion.Another manufacture's limbs were used with the endurant ii main body.It was reported that, approximately two months after the implant procedure, the patient developed eosinophilia, generalized edema, and renal insufficiency.A ct showed no abnormal findings at the stent graft implant site, and the cause remains unknown.The operating doctor and a physician were investigating the cause, and they suspected if it was some kind of allergic reaction to stent graft implantation.However, the cause was not able to be definitely confirmed after the investigation.No additional treatment is planned.No additional clinical sequelae were reported and the patient is being monitored by their physician.

• Brand Name: ENDURANT II 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: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 6879200
• MDR Text Key: 86747659
• Report Number: 2953200-2017-01461
• 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: 08/25/2017

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: 03/22/2019
• Device Model Number: ETBF3216C145EJ
• Device Catalogue Number: ETBF3216C145EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/20/2017
• Date Device Manufactured: 03/22/2017
• 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): Other
• Patient Age: 83 YR