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

Model Number	ENBF3620C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Abdominal Pain (1685); Myocardial Infarction (1969); Rupture (2208)
Date of Event	08/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 unknown diameter abdominal aortic aneurysm.Approx.7 years, 4 months post index procedure, it was reported that the patient presented emergently with abdominal pain.A ct revealed a large aaa with an endoleak and intra-abdominal blood suspicious for an aortic rupture.The ct showed that both implanted limbs were ¿floating¿ in the aaa sac due to type ib endoleaks from disease progression.The right limb along with the entire iliac artery was occluded.It was noted that the neck area appeared to be quite dilated with a possible type ia endoleak and it looked like the stent graft had slipped down 6mm below the renals.The aortic neck diameter was 34mm and the aaa diameter was 82mm.Neck length was 6mm with a proximal neck angulation of 45 degrees.Intervention was carried out with the implantation of an endurant aui and extension to the external iliac artery with two further limbs.Touch up was then performed using a reliant balloon.4 endoanchors were implanted near the top of the aortic aui implant to enhance seal and fixation.Angiogram showed good patency and no sign of an endoleak.A left to right fem-fem bypass was also carried out.It was reported that the patient had an mi during the procedure, but the patient was reportedly stable by the next morning.As per the physician, the cause of the event was due to disease progression and potentially the patient was lost to follow up.No additional clinical sequalae were reported and the patient will be monitored by their physician.

• 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: 7849699
• Report Number: 2953200-2018-01268
• Device Sequence Number: 14080339
• Product Code: MIH
• UDI-Device Identifier: 00613994762351
• UDI-Public: 00613994762351
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: 02/28/2013
• Device Model Number: ENBF3620C166E
• Device Catalogue Number: ENBF3620C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2018
• Initial Report FDA Received Date: 09/06/2018
• 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: 70 YR