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

Catalog Number ENUF3614C105EE

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

Additional film review was completed.The exact cause of the event is unknown; however an investigation is ongoing.

Manufacturer Narrative

Notify date corrected to (b)(4) 2014.

Event Description

An endurant aui stent graft system was implanted for the endovascular treatment of a 5.1 cm diameter abdominal aortic aneurysm.The proximal aortic neck was 32 mm in diameter, the distal aortic neck was 13 mm in diameter, and the length was 12 mm.The neck was reported to have thrombus, the right common iliac artery was occluded, and the left common iliac artery was "full of calcification".The left external iliac artery was very narrow, 4-5 mm in diameter.The vessels were non-tortuous.It was reported that the physician implanted the stent graft.While deploying the graft, the bare stent with anchor pin was partially deployed, despite the physician fully rotating the back end wheel of the delivery system.A reliant balloon was used to complete deployment of the stent graft.No clinical sequelae were reported and the patient is fine.A review of returned angio images during implant revealed that a stent was initially seen within the right common iliac; the right iliac was occluded.The left iliac appeared extensively diseased along its length, and this was ballooned prior to implant.From the left side, the aui was brought up to position just below the renals.The neck flow lumen diameter was approximately 25mm and was essentially straight, measured l-r.Unknown angulation a-p.After deploying the 1st several stents, the suprarenal stents were released.With the spindle seen near the level of the apices and the tip positioned at stent graft centerline 1 cm above the stents, the apices of the suprarenal stents appeared not to be fully expanded, and are possibly entangled.The spindle is then seen recaptured in the tip and was pulled down into the stent graft and the delivery system was then removed.After repetitive ballooning wit hin and above the stent graft aortic body, the suprarenal stents appeared less constrained but still possibly not fully opened.It could not be confirmed if 2 opposing stents remained entangled.The cause could not be determined.May be anatomy related; thrombus within the suprarenal neck may have contributed.May have been caused by a delivery system issue; the delivery system was discarded.Cta¿s from 6 days post-implant showed that the aui was positioned just below the renals.The suprarenal stents were not entangled.There is an aortic dissection seen from the aui proximal graft margin extending proximally up the thoracic aorta.The suprarenal stents do not appear fully expanded to the right side of the aortic wall; the suprarenal stent diameter, the aui od is 26mm, and the aortic wall diameter is 33mm.Some thrombus is seen within the proximal aortic body.No endoleak is seen and the aaa max diameter is 5cm.The limb is patent.A fem-fem bypass has been placed.No other stent graft issues were observed.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDURANT
• 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: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 4221146
• MDR Text Key: 5255106
• Report Number: 2953200-2014-02276
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

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: 04/12/2015
• Device Catalogue Number: ENUF3614C105EE
• Device Lot Number: V04027631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 11/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2014
• Date Device Manufactured: 04/15/2013
• 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: 00074 YR