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

Catalog Number ETBF3220C166EE

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Separation Failure (2547); Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 05/14/2014

Event Type  Injury  

Event Description

An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic lesion.It was reported that the physician attempted to implant a 32x20x166 bifurcate into a slightly angulated proximal aortic neck.The stent graft was deployed, the delivery system was advanced, and the tip was recaptured.The physician then attempted to pull back the delivery system and felt slightly more resistance than usual.Imaging showed that three of the suprarenal stents were entangled and caught on the tapered tip.The physician had difficultly removing the device at this point.Another vessel puncture was made and a reliant balloon was advanced up the same side.The balloon was used to successfully disconnect the stents from the tapered tip.The delivery system was then removed from the patient, and the physician attempted to model the stent graft with only limited success.The stent graft had been pulled down from its original position, and part of the proximal end of the stent graft was not fully adhering to the aortic wall.The physician was concerned about the potential for a type i endoleak, and decided to convert the patient to a n aui system.Additional stent grafts were retrieved from other local hospitals, causing a delay in the progression of the case.A 32x32x49 endurant cuff was first implanted to prevent the suprarenal stents of the bifurcated stent graft from wearing the fabric of the aui device, and then a 32x14x102 endurant aui was placed in the aorta with a talent occluder placed in the contralateral iliac.Final angiography showed a good result with no evidence of endoleak.No additional clinical sequelae were reported, and the patient will be monitored.A review of returned angiography images at implant revealed that the bifurcate was seen with the recaptured tip positioned, and possibly caught, within the suprarenal stents.Several of the suprarenal stents appeared entangled with each other.One of the 4 proximal markers is seen approximately 1cm below the other 3 proximal markers (which are on the same plane), and at least one of the suprarenal stents appeared to have been pulled down below the level of the proximal graft margin.The cause of the entanglement and removal difficulties could not be determined.There were no images provided showing placement of the bifurcate prior to deployment, deployment of the proximal stent graft, release of the suprarenal stents, and no images showing the tip recapture.The contralateral limb was not deployed into the gate.No contrast was seen in the initial images; therefore, any possible type i endoleak could not be assessed.The bifurcate aortic body was then seen ballooned.The aortic cuff and aui were seen implanted several cm's above the bifurcate; the aui was implanted up the right side excluding the contra gate.Ballooning was performed throughout the stent graft.No stent graft issues were seen with the aui/cuff.Cta¿s from 5 days post-implant revealed that the aui and aortic cuff were positioned just below the lowest left renal artery.The aortic diameter at the level of the celiac was 23x28mm, at the sma was 26mm, and at the left renal measured 25mm.The proximal neck was moderately angulated l-r and p-a (amount of angulation is currently unknown).At the flow divider contrast is seen diverted to the right ipsilateral limb; the contra limb was not implanted.No endoleak is seen.The max aaa diameter is 5.6cm.The distal ipsilateral limbs were placed into the right common iliac.It is unknown if the patient anatomy may have contributed.Analysis of the returned delivery system noted a very slight kink in the graft cover 6 cm from the distal edge.Additionally, the distal edge of the graft cover had a small degree of damage.The rest of the device was unremarkable.Microscopic inspection of the sleeve and spindle revealed no damage or abnormalities.The root cause of the removal difficulties could not be conclusively determined; however, vessel morphology may have contributed.

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
• 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: 3870730
• MDR Text Key: 21240848
• Report Number: 2953200-2014-01188
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2016
• Device Catalogue Number: ETBF3220C166EE
• Device Lot Number: V04236246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2014
• 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 Outcome(s): Required Intervention