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

Catalog Number ETBF2316C124EJ

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

An endurant stent graft system was implanted in the patient for the endovascular treatment of a 58mm abdominal aortic aneurysm.Aneurysm and vessel morphology was reported as the diameter of the upper proximal neck is 20mm.The diameter of the aneurysm entry is 20 mm.The proximal neck length is 34mm.It was reported that during withdrawal of the delivery system, one suprarenal stent got entangled with another suprarenal stent and it was attributed to the physician pulling the delivery system down rather forcibly.No endoleak was noted due to the stent entanglement.There were no injuries to the patient.No clinical sequelae were reported and the patient will be monitored by the physician.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDURANT II
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 4085731
• MDR Text Key: 4851360
• Report Number: 2953200-2014-01817
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2016
• Device Catalogue Number: ETBF2316C124EJ
• Device Lot Number: V04228794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2014
• Date Device Manufactured: 03/12/2014
• 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 Age: 00081 YR