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

Catalog Number ETBF3216C124EE

Device Problems Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

A endurant ii stent graft system was implanted for the endovascular treatment of a 5.5 cm diameter abdominal aortic aneurysm.The proximal neck diameter was 28mm, with a length of 40 mm.The distal neck diameter was 26 mm, the right iliac was 15 mm in diameter, and the left iliac was also 15 mm in diameter.It was reported that the surgeon attempted to implant the stent graft.After the device was positioned, the physician attempted to deploy the graft.Two suprarenal stent springs of the graft failed to deploy properly.The tip capture operation had been accomplished without difficulty.The physician then used a balloon directly on the springs to resolve the issue, despite this procedure being outside of ifu.The ballooning failed to deploy the stent graft springs.The physician plans to continue routine follow up; no intervention is anticipated at this time.No clinical sequelae were reported and the patient is fine.The physician believes the problem was caused during assembly of the stent graft.The graft remains implanted and the delivery system was discarded by the customer.An evaluation of films pre-implant showed that the proximal neck diameter (flow lumen) was approximately 29mm at the celiac, 26x28mm at the sma, and 23x26mm at the renals, with little thrombus or calcification.There was negligible neck angulation l-r, but some a ngulation in the a-p.The maximum diameter aaa was 5.5cm.A single still angio image at implant post-deployment of the bifurcate shows that there is possible entanglement of 2 of the suprarenal stents.It is unclear if the stents are adjacent to each other.The neck has negligible angulation.No other stent graft issues are observed.No additional intra-op images were provided, and post-implant films were not available.The cause of the possible suprarenel entanglement is unknown.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

A review of films showed the patient neck diameters were reported to be 24 and 28 mm; a 32 mm bifurcate was used to treat the patient.The 24 and 28 mm diameters appear to have been measured from an axial cross section from the pre-op ct scan.These measurements are taken at an angle relative to the aortic centerline.Neck measurements from a plane normal to the aortic centerline result in neck diameters of 22 and 23 mm ¿ essentially the 32 mm device appears to be excessively oversized for the patient anatomy by ~40% (recommended oversizing is 10-20%).This oversizing likely contributed to the stent apices on the anterior vessel wall landing in close proximity to one another where the delivery system was biased up against the vessel wall.In these conditions, where the stent is excessively constrained from expanding, having one stent peak deflected inwards is a stable state that the suprarenal stent can end up in.It is possible that the stent was pulled in slightly when the spindle was disengaged from the stent peaks during tip recapture; this could have contributed to the stent peak getting pulled into the vessel lumen.This graft orientation and behavior is believable given the oversizing in this patient.There is no evidence of any manufacturing defect in the stent graft or delivery system.There is also no evidence of any endoleak or other patient complication resulting from the stent peak being deflected inwards.Not following ifu: (ballooning outside the stent graft and oversizing the stent graft) other: single suprarenal stent apex remained deflected inward post-deployment.

• Brand Name: ENDURANT II
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: ludmila voulfson ; 3576 unocal place; santa rosa, CA 95403 ; 7075661229
• MDR Report Key: 3672680
• MDR Text Key: 4319661
• Report Number: 2953200-2014-00449
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2016
• Device Catalogue Number: ETBF3216C124EE
• Device Lot Number: V04195583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2014
• Date Device Manufactured: 01/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 00066 YR