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

Catalog Number ETCF3232C49E

Device Problems Difficult to Remove (1528); Inaccurate Delivery (2339); Folded (2630)

Patient Problem Occlusion (1984)

Event Date 01/29/2014

Event Type  Injury  

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.The proximal aortic neck was 28 mm in diameter and 40 mm long with mild angulation (less than 15 degrees) and mild calcification.The maximum aneurysm diameter was 57 mm.The diameter of the distal aorta was 25 mm.The lowest renal artery was on the left.It was reported that a proximal type i endoleak was present after implanting the bifurcated stent graft and contralateral limb.The decision was made to treat this with an endurant cuff.The physician successfully deployed the cuff approximately 1 cm above the bifurcate and then attempted to push the catheter proximally to recapture the tip.At this time the spindle caught on the apex of the cuff suprarenal stent.The physician attempted to pull the device distally, but the spindle remained stuck on the stent and pulled the device inwards causing the cuff to infold.The physician then attempted to push the device proximally and rotate counterclockwise.This caused the aortic cuff to wrap around the catheter, constraining the cuff to approximately 10 mm in diameter.The cuff also moved up so that the distal edge of the cuff was in line with the proximal edge of the bifurcate.The physician then rotated the opposite direction to unwind the cuff.The physician then pushed the device proximally until the entire cuff was proximal to the bifurcate, covering the celiac and sma.At this point the distal edge of the cuff was in line with the proximal edge of the bifurcate.The physician then cannulated both the sma and the celiac from the groin between the extension and bifurcated device.A 10mmx80mm self-expanding stent was placed in the celiac, extending between the cuff and bifurcate and into the proximal part of the main body.A 4mm balloon was placed in the distal aspect of the ses, and a balloon expandable stent was placed within the distal portion of the ses to maintain patency.While cannulating the sma and celiac to place the stents, the aortic cuff was further pushed up on the patient¿s right anterior side maintaining blood flow to the sma.Final angiogram showed no remaining infolding of the cuff, but the distal edge of the device was pushed up on the right side.Two of the cuff's suprarenal stents remained entangled.No additional clinical sequelae were reported.

Manufacturer Narrative

(b)(4).Evaluation results: inherent risk of procedure (stent graft misplacement).(insufficient information; cause is unknown).Incorrect technique/procedure (possible failure to adequately rotate the device before advancing proximally to recapture the tip).Evaluation conclusions: known inherent risk of a procedure (stent graft misplacement).(insufficient information; cause is unknown).Use error caused or contributed to the event (possible failure to adequately rotate the device before advancing proximally to recapture the tip).

• 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: 3640588
• MDR Text Key: 4279870
• Report Number: 2953200-2014-00321
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2015
• Device Catalogue Number: ETCF3232C49E
• Device Lot Number: V04030414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2014
• Date Device Manufactured: 04/19/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00070 YR
• Patient Weight: 54