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

Model Number	ETBF2516C145E
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Intimal Dissection (1333); Extravasation (1842); Occlusion (1984); Thrombus (2101); Injury (2348); Blood Loss (2597); Diminished Pulse Pressure (2606)
Date of Event	06/28/2018
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 a 57 mm diameter abdominal aortic aneurysm.During the index procedure, it was reported that while the physician was balloon moulding the ipsilateral limb of the main body stent graft, the balloon was over inflated causing dissection of the right limb and extravasation.A non-medtronic stent was implanted to cover the right hypogastric artery at the distal end of the ipsilateral limb, to cover the dissection and stop the bleeding.The proximal end of the non-mdt stent was post dilated using a 14 mm balloon to seal and extend into the main body of the endurant ipsilateral limb.The procedure was completed with no sign of an endoleak.Later that day, the patient's limb became occluded with diminished pulses due to the implanted non-mdt stent graft dead ending into the tortuous external iliac.A mechanical thrombectomy was performed with a non-medtronic catheter to remove the majority of the clot and another manufactures stent graft was placed within the previously implanted non medtronic stent graft down the external iliac.The endurant ipsilateral limb was then relined using another endurant limb to trap any remaining clot in the limb.The final angiography showed no abnormalities and the patient had good pulses.As per the physician, the cause of the event was user error.No additional clinical sequela were reported and the patient is fine.
Additional Manufacturer Narrative
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: 7705775
• Report Number: 2953200-2018-01072
• Device Sequence Number: 2542464
• Product Code: MIH
• UDI-Device Identifier: 00613994991263
• UDI-Public: 00613994991263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 02/13/2020
• Device Model Number: ETBF2516C145E
• Device Catalogue Number: ETBF2516C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: 72 YR