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

Catalog Number ESBF3614C103E

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Injury (2348)

Event Date 01/08/2015

Event Type  Injury  

Event Description

An endurant iis stent graft system was inserted into the patient for the endovascular treatment of a 6.2 cm in diameter abdominal aorta aneurysm.Vessel morphology was reported as there was severely angulated aortic neck 90 degree at the renal artery and 3 cm distally there was another curve in the aortic neck.The stent graft delivery system was advanced to the intended landing zone over a 185cm meier wire.It was reported that after completely deploying the stent graft delivery system, the physician was unable to recapture the spindle into the nose cone.The deployment of the stent graft was successfully performed.During removal of the delivery system, the spindle was not able to be retracted through the angle of the neck where the bare spring attaches to the graft.The physician was unable to remove delivery system, due to the severe angulations in the aortic neck.The fabric of the stent graft was accordion due to the spindle being caught on the fabric.The physician elected to surgically convert the patient to an open repair, the bifurcated graft was cut off 1cm below the bare spring and the iliac limb remains in the patient.The open repair graft was sewn to the proximal end of the stent graft.It was noted that the spindle was caught on the edge of the stent graft fabric, which pulled on the suprarenal strut.The spindle could not get reseated, due to the severe angulation of aortic neck.No clinical sequelae were reported and the patient is fine.Review of cta¿s pre-implant confirmed that the patient¿s proximal neck was severely angulated 90 deg rt-lt and 55deg a-p.The proximal neck diameter was 29 ¿ 31mm and contained thrombus.The max diameter aaa was 6cm and also contained thrombus; 2 - 3 cm flow lumen.The distal aorta measured 22 x 31mm and was calcified.The iliacs were non-tortuous and moderately calcified; bilaterally.The cause of the removal difficulties leading to the surgical conversion could not be determined.Images during implant were not provided.However, it is likely that the severely angulated neck contributed to the events.

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: 4475576
• MDR Text Key: 5323073
• Report Number: 2953200-2015-00186
• 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: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2016
• Device Catalogue Number: ESBF3614C103E
• Device Lot Number: V05949454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 02/02/2015
• Date Device Manufactured: 10/14/2014
• 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
• Patient Age: 00076 YR
• Patient Weight: 59