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

Model Number	ENBF2316C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of a 5.6 cm in diameter abdominal aortic aneurysm.The vessel morphology was reported the proximal aorta was 21-19-20 mm in diameter.The right iliac artery was 18 mm in diameter and there was 20 mm between the bifurcation and the right hypogastric artery.The left iliac artery was 16-17 mm in diameter.The femoral arteries were 7-8 mm in diameter.It was reported that a recent ct revealed that there was a possible type iii fabric endoleak in the endurant stent graft bifurcate or a possible type ii endoleak.There was contrast observed at the level of the flow divider near the origin of the inferior mesenteric artery and lumbar arteries.Currently the aneurysm is 6.4 cm in diameter.No clinical sequelae were reported and the patient will be monitored by the physician.
Additional Manufacturer Narrative
Film review: the cause of the reported type iii endoleak seen near the level of the flow divider could not be determined from the films provided.Ct¿s returned from 56 months post-implant revealed no obvious proximal or distal endoleak.Near the level of the flow divider the stent graft od within the distal neck which was extensively calcified measured ~21mm.There was ~25mm of contra limb overlap seen within the gate.Although a type iii fabric endoleak cannot be ruled out, no clear endoleak was observed near the bifurcate flow divider.Possible contrast was seen near the flow divider within the top of the sac, along the calcified posterior distal neck.However, this may have been reflectance from calcification or from a stent graft marker band artifact.Non-contrast studies were not available for comparison.A lumbar artery was seen near this same area along the posterior aorta which may have also been feeding the aaa.No other stent graft issues were observed.
Additional Manufacturer Narrative
Corrected information: sex, date of birth, no eval explain code.Information is provided in the future, a supplemental report will be issued.

• 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: 6563832
• Report Number: 2953200-2017-00773
• Device Sequence Number: 616866
• Product Code: MIH
• UDI-Device Identifier: 00613994762290
• UDI-Public: 00613994762290
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup,Followup
• Report Date (Section B): 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: ENBF2316C145E
• Device Catalogue Number: ENBF2316C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided; 05/17/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 06/05/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR