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

Model Number	ENBF3216C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/06/2017
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 abdominal aortic aneurysm of unknown size.A heli-fx applier and endoanchors were used in the endovascular treatment of a type ia endoleak in the patient.It was reported that the patient returned for follow up exam and a ct exam showed a type ia endoleak.It was noted that no migration of the stent graft was observed but that aortic neck dilatation had occurred, and this had effected the proximal seal.During the procedure after successful implantation of a 36mm endurant aortic cuff and 5 endoanchors, it was noted that on attempted loading of the 6th anchor, it would not load.After several unsuccessful attempts to load the 6th endoanchor involving pressing the forward and reverse mechanism multiple times, it was noted that a broken piece of an endoanchor exited the heli-fx applier.It was unknown when the fracturing of the endoanchor occurred.It was noted that the event was resolved with no further treatment.As per the physician the cause of the endoleak was due to anatomical dilatation of the aortic neck to 31.4mm.The existing 32mm bifurcation stent graft lacked the oversizing to successfully seal infrarenally.As per the physician, the cause of the endoanchor event was product related.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: 7137276
• Report Number: 2953200-2017-02028
• Device Sequence Number: 1091555
• Product Code: MIH
• UDI-Device Identifier: 00613994762429
• UDI-Public: 00613994762429
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/21/2017

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: 09/22/2013
• Device Model Number: ENBF3216C166E
• Device Catalogue Number: ENBF3216C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 12/21/2017
• 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: 74 YR