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

Catalog Number ETBF3616C166E

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

Patient Problem Injury (2348)

Event Date 05/01/2015

Event Type  Injury  

Event Description

An endurant ii stent graft system were implanted for the endovascular treatment of an abdominal aortic aneurysm.The aortic neck was angulated.The proximal aortic neck measured 26.4 mm in diameter and 17.5 mm in length.The right common iliac artery measured 15 20 19 19 15 in diameter, and the left common iliac artery measured 12 12 15 15 in diameter.The right femoral artery measured 9-10 mm in diameter and the left femoral artery measured 9-9.5 mm in diameter.It was reported that the stent graft was deployed in the angulated aortic neck.The stent graft was released and the entire body deployed.During the tip recapture and removal of the delivery system, the physician pulled down the delivery system and the spindle of the delivery system got caught on the suprarenal stents.As a result, the suprarenal stent flipped downward and was stuck in a perpendicular angle to the flow lumen.Angiogram revealed proximal type i endoleak due to stent pulling fabric away from aortic wall in seal zone.The physician tried to use sheath and balloon to push stent back up but was unsuccessful.The stent kept going back to its deformed state.Physician used a 32 mm cuff from another manufacturer to push stent back and ballooned.The stent was pushed back, however, there appeared to be lack of wall apposition.Subsequent angiogram revealed that the proximal type i endoleak lessened but persisted.Physician determined best course of action was to close the patient, consult with another physician, and possibly treat at later date due to amount of contrast used.The physician stated the event was related to the procedure.The physician stated that the cause of the suprarenal stent got caught on the spindle of the delivery system was due to patient's angulated anatomy.It was later reported that when the physician released the suprarenal stents from the spindle, all the stents were released, however, it appeared one of the stents was caught in another and did not fully independently release.Prior to spindle recapture, the delivery system was rotated, moved proximally to stents, and the spindle was fully recaptured above the suprarenal stents.During the delivery system removal, the tapered tip was biased against the patient's right side of the aorta.Torquing of the delivery system was attempted by the physician during removal but the bottom part of the spindle continued to get caught on the stent.No additional clinical sequelae were reported that the patient is being monitored.Films analysis and review: pre-implant cta¿s revealed that the patient had an irregular shaped and angulated proximal neck.The proximal neck flow lumen diameter near the level of the renals was 21 x 29mm, 1cm below was 28x25mm and 1.5cm below the renals was 27mm.Proximal to the renals, the aortic diameter measured 22mm at the celiac and 23x24mm at the sma.The neck contained areas of calcification and thrombus.The suprarenal neck was angulated 55deg (l-r) and the infrarenal neck was angulated 45deg (r-l) and 40deg (a-p).The max diameter aaa was 6.3cm.The distal aortic diameter was 28mm and calcified.The right iliac was moderately tortuous and extensively calcified, the diameter ranged from 15 ¿ 20mm.The left iliac was mildly tortuous with some areas of calcification, and the diameter ranged from 11 ¿ 15mm.Several still angio images at implant revealed that the main device was brought up the right side.The proximal neck was irregularly shaped.The flow lumen diameter just below the renals measured approximately 22mm l-r and bulged out to 31mm; 1cm below the renals (per the marked pigtail).The suprarenal and infrarenal neck was angulated approximately 45 deg per this 2d image.The bifurcate was seen implanted approximately 1cm below the renals, and there appeared to be a proximal type i endoleak.One of the suprarenal stents on the right side was positioned 90 deg inward with the anchoring pin at the level of the stent graft proximal fabric and ¿e¿ marker, and two other suprarenal stents on the right side are possibly entangled with each other.No other stent graft issues are observed.The cause of the proximal type i endoleak appears likely due to one of the suprarenal stents being folded inward, and 2 other suprarenal stents possibly entangled, causing the proximal stent graft to be deployed asymmetrically leading to a loss of stent graft apposition.The cause of the malpositioned suprarenal stents could not be determined.Images during deployment of the stent graft and the suprarenal stents, as well as during tip recapture and removal of the delivery system, were not seen in the films provided.It is possible that implanting within the patient¿s angulated and irregular shaped proximal neck, and oversizing of the bifurcate, may have contributed.No obvious stent graft issues could be seen which could explain the reported events.

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: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 4796573
• MDR Text Key: 5836070
• Report Number: 2953200-2015-00938
• 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: 05/01/2015

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: 12/18/2016
• Device Catalogue Number: ETBF3616C166E
• Device Lot Number: V05997337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/26/2015
• Date Device Manufactured: 12/19/2014
• 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: 00080 YR