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

Model Number	ETBF3620C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system were implanted for the endovascular treatment of a 5.7 cm in diameter abdominal aortic aneurysm.It was reported that the bilateral common femoral arteries were exposed and controlled with cease loops.The arteries were access with an 18ga needle and 9 fr sheaths.A guide wire was placed in the descending thoracic aorta distal to the lsa from the right common femoral.From the left a pig tail catheter was place to the level of l1-l2 disc space.An aortogram was perform and an endurant bifurcated stent graft implanted distal to the left renal artery and extended proximal to the right hypogastric artery the delivery system was then remarried.At this point a glide wire was used to straighten the pig tail out and the glide wire along with the marker pig tail catheter was pulled distal to the gate.The pigtail was reformed and advanced into the gate without issue.The pig tail catheter was spun to confirm gate cannulation.A guidewire was placed into the marker pig tail catheter and advance to the descending thoracic aorta distal to the lsa.A marker on the catheter was lined up with the flow divider marker of the endurant bifurcate.The c-arm was placed in an rao projection and an angiogram was performed though the sheath.The catheter was removed and replaced with an endurant stent graft limb.The limb was placed proximal to the left hypogastric artery.The delivery systems were removed and replaced with 16fr sheath.Reliant balloons were placed thought both sheaths.The proximal stent graft, the bifurcate, and the limbs were ballooned with no issue.The reliant balloons were removed and the marker pig tail catheter was placed on the left wire.The post stent graft angiogram revealed a proximal type i endoleak.The physician elected to implant heli-fx aptus endoanchors to attempt to correct the proximal type i endoleak.The aptus endoanchors were placed in the following locations on the left: 90 degrees (ap), rao 30, and rao 60 degrees.On the right 2 aptus endoanchors were placed in an ap projections on the right side of the graft.All aptus endoanchors were placed in the proximal edge of the graft.The heli-fx guide was removed and the pigtail catheter was advanced proximal to the renal arteries.A repeat post aptus / stent graft aortogram was performed showing that the proximal type i endoleak has been reduced.The physician elected to end the procedure and have the patient follow up at a later date.The arteries were closed with no issue.Per the physician, the cause of the event was unknown.No additional clinical sequelae were reported and the patient will be monitored by the physician.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6523045
• Report Number: 2953200-2017-00676
• Device Sequence Number: 797327
• Product Code: MIH
• UDI-Device Identifier: 00613994991065
• UDI-Public: 00613994991065
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: ETBF3620C166E
• Device Catalogue Number: ETBF3620C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR