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

Catalog Number ETBF2516C145E

Device Problems Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Date 04/03/2014

Event Type  Injury  

Event Description

An endurant stent graft system was implanted for the endovascular treatment of a 5 cm in diameter abdominal aortic aneurysm.Vessel morphology was reported as straight forward.It was reported that the bifurcated stent graft was deployed in aorta down to gate level.The physician deployed the suprarenal stents, (there were no issues or difficulties noted during the rotation of the thumb wheel for the deployment of the spindle) the nose cone was advanced all the way up however the apices did not deploy.The suprarenal stents remained in the constrained position even though the nose cone was advanced the way up.The physician deployed rest of ipsilateral limb, the physician rotated the delivery system attempting to release the suprarenal stents.After rotating the delivery system several 360' rotations, it was apparent that the suprarenal stents were stuck and did not expand to adhere to the vessel wall.The physician decided to cannulate the gate and advance a modelling balloon, attempting to release the suprarenal stents.However the apices did not expand.The physician placed a balloon in the aortic neck of the aneurysm and pulled down on the delivery system to manually bring it through the stents.That resulted in the suprarenal stents inverting into the stent graft.The physician used another manufacturer¿s balloon to salvage the case and pushed the suprarenal stents up reposition the top (fabric) of the stent graft up to the renal artery.No clinical sequelae were reported and the patient is fine.The returned delivery system was evaluated.Upon inspection of the device, the tapered tip and spindle were stuck within a sentrant sheath.There was a 2 mm gap between the external slider and front grip.The spiral cut lumen was damaged and unravelling in multiple locations.The thumbwheel was not returned with the delivery system.The thumbwheel t-tube was advanced all the way forward and could not be moved back to its starting position due to the damage to the spiral-cut lumen.The sentrant sheath hub was broken down to allow for removal of the capture components from the valves.Once the hub was removed, it revealed that the valve was stuck over the entire length of the exposed spindle.Once the valves were removed, there was a 22mm gap between the graft cover and tapered tip.The tapered tip sleeve was advanced forward 4 mm from the spindle.The graft cover was retracted to expose the spiral-cut lumen, which had significant damage.There was a complete break of the spiral-cut lumen 14 mm from the proximal end of the spindle.There was also unraveling of the spiral cut lumen combined with kinking at multiple locations along its length.Microscopic inspection of the sleeve and spindle revealed no damage or abnormalities.The complaint was confirmed; there was significant damage to the spiral-cut lumen, likely caused by the manipulation of the device during attempts to free the supra-renal stents.The root cause of the deployment difficulty could not be conclusively determined.Reviewed of several still angiograms images at implant was completed.A single image showed that when the tip/sleeve was approximately 1cm above the spindle, all of the suprarenal proximal apices have not been released and are still attached near the top of the spindle.Another image shows that when the spindle had been pulled down to near the level of the proximal fabric, the proximal apices are again attached to each other (and likely entangled).Ballooning within the proximal stent graft is performed, and final images revealed that all the apices appear to have been released; however, some of the suprarenal stents are malpositioned inward and downward, and the 4 proximal markers are not in the same plane.A single angiogram image showed that the final position of the stent graft appeared to be just below the renals, and no obvious endoleak was observed.The cause of the suprarenal stents failing to open could not be determined from these images.

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: 3785279
• MDR Text Key: 4436385
• Report Number: 2953200-2014-00897
• 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: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2015
• Device Catalogue Number: ETBF2516C145E
• Device Lot Number: V04062975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• 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: 00074 YR