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

Model Number	ENBF2816C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: enlw1624c93e sn (b)(4), use by date: 2013-09-06, udi # (b)(4), etcf3232c49e sn (b)(4), use by date: 2017-01-04, udi # (b)(4).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 stent graft system was implanted in the patient for the endovascular treatment of an abdominal aortic aneurysm.Vessel morphology at implant was not reported.It was reported that at approximately 23 months post implant an angiogram revealed a type ii endoleak.The physician elected to coil the hypogastric artery and implant a 16x10x156 endurant limb that was extended into the right external iliac artery.The left iliac limb was extended with a 16x24x93 endurant limb above the left hypogastric artery and a 32x32x49 endurant cuff was implanted proximally.It was reported that 24 months later additional a recent ultrasound revealed that there was aneurysm enlargement that was due to an unknown endoleak.A ct was not performed.The next day an aortagram revealed a distal type iii separation endoleak, the 16x10x156 endurant stent graft had been pulled out and separated from the 16x24x93 endurant limb on the right iliac limb from the original implant.The physician implanted a 16x16x124 endurant iliac limb to reconnect and close the gap between the limbs.This was successfully done and the iliac limb was ballooned.Another aortagram was performed and the type iii separation endoleak was resolved, however there was still an apparent endoleak coming from proximal portion of the stent graft.There was a type iii separation endoleak of approximately 1cm, between the endurant bifurcated stent graft and the endurant 32 aortic cuff.Another 32x32x49 endurant aortic cuff was implanted with the bottom of the cuff landing at the original bifurcation followed by 2 kissing 16x16x82 iliac limbs in each iliac reaching just above the level of the bottom of the original cuff.These limbs were ballooned and another aortagram was performed.All of the endoleak had been resolved and the procedure was concluded.Per the physician, the cause of the iliac limb type iii separation endoleak was iliac separation due to tortuosity in the iliac.However the cause of the proximal type iii separation endoleak us unknown.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT 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: 6707653
• Report Number: 2953200-2017-01121
• Device Sequence Number: 16403593
• Product Code: MIH
• UDI-Device Identifier: 00613994762481
• UDI-Public: 00613994762481
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2017

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: 06/26/2013
• Device Model Number: ENBF2816C166E
• Device Catalogue Number: ENBF2816C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/12/2017
• 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: 84 YR