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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ENDURANT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
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).
 
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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 Key4475576
MDR Text Key5323073
Report Number2953200-2015-00186
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100021
Number of Events Reported1
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 Date10/13/2016
Device Catalogue NumberESBF3614C103E
Device Lot NumberV05949454
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2015
Initial Date FDA Received02/02/2015
Date Device Manufactured10/14/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age00076 YR
Patient Weight59
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