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

Catalog Number ETBF3616C145EJ

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2015

Event Type  malfunction  

Event Description

An endurant ii stent graft system was implanted in the patient for the endovascular treatment of a fusiform abdominal aortic aneurysm.Aneurysm and vessel morphology was not reported; however, it was noted severe infrarenal tortuosity (about 90 degrees) and the proximal neck was about 10mm in length.It was reported that during the procedure the physician used a heat gun in order to bent the bifurcation delivery system 90 degrees.The main body was implanted without issues.However, during the removal of the delivery system, the suprarenal stent of the main body caught the spindle of the delivery system.Then, the delivery system was half rotated clockwise, and the delivery system was moved back and forth in order to release the entanglement.When the physician retracted the distal tip into the outer sheath (graft cover) for docking, it was confirmed that the distal tip and inner member were detached from the delivery system.The distal tip was caught by snare, and both distal tip and inner member were stored into another manufacturer¿s dry seal sheath, and the delivery system was successfully removed from the patient.The physician attributed the malfunction due to using the heated gun about 120 degrees and intentionally bending the graft cover where the stent graft was stored (from the proximal end of the graft to the third stent) and the outer sheath (graft cover) causing the material to become fatigue.In addition; the delivery system was rotated putting pressure when it was moved back and forth leading to detachment.No additional clinical sequelae were reported and the patient is doing fine.The device was returned and its evaluation is complete.The event was confirmed; the tapered tip was detached completely from the delivery system.The root cause of the event could not be conclusively determined during analysis however, off-label use and the patient's severely tortuous aortic neck likely contributed.Review of several returned still angio films at implant confirmed that the device was brought up the right side and deployed within the angulated neck.The tip was seen with the sleeve within the aortic body and proximal tip at the level of the suprarenal stents.The graft cover and spindle were positioned distal to the deployed ipsilateral limb, and the contra was not implanted.Another image showed that the tip was pulled down into the aortic body; the proximal end of the tip is bent, and the distal end of the tip had been snared.The suprarenal stents appeared entangled and the contra gate has been cannulated.The next image showed that the detached tip was still snared and had been pulled into the ipsilateral limb.The events were confirmed; however the cause could not be determined from the several still images provided.Complete images during stent graft delivery, deployment and delivery system removal were not returned.

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: 4782988
• MDR Text Key: 19359877
• Report Number: 2953200-2015-00910
• 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: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2016
• Device Catalogue Number: ETBF3616C145EJ
• Device Lot Number: V05904380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2014
• 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: 00090 YR