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

Model Number	ETBF2313C145E
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/15/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 ii stent graft system was implanted in a patient for the endovascular treatment of a 50mm diameter abdominal aortic aneurysm.The aortic neck was 44mm in length, 19mm in diameter proximally and 21mm in diameter distally.The left iliac artery was 9mm, 8mm 10mm in diameter from proximal to distal and it was calcified.The right iliac artery was 10mm, 13mm in diameter from proximal to distal and it was calcified.The external iliac arteries were 7mm in diameter bilaterally.The aortic bifurcation was narrow measuring 17mm in diameter.There was no endoleak post implant and both limbs were patent.It was reported that a suspected perclose failure was treated with an open procedure on the left common femoral.The patient returned again emergently and the left limb and external iliac were occluded and the stent graft was assessed with ivus.The proximal left limb was compromised / pinched by the right limb in the distal aorta.Thrombus was present in the left limb and external iliac arteries.The patient was treated with angiojet to minimize thrombus burden in the limb and distal main body.The left limb was treated by placement of another manufacturer¿s stent and bilateral kissing balloons.Ivus was used to confirm patency of both limbs following treatment.Residual thrombus was present in the main body however, no further treatment was done.The physician stated the cause of the event cannot be determined.It was also reported that the patient died due to an unknown cause.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported events could not be conclusively determined from the pre-implant 3d recon report provided.Films at implant and films that showed the reported events were not provided for review and comparison.The pre-implant 3d recon report showed that the distal aorta was narrow, measured only ~17 mm and was heavily calcified.Implanting the stent graft in a narrow and heavily calcified distal aorta may have contributed to the events.
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: 6619989
• Report Number: 2953200-2017-00939
• Device Sequence Number: 650049
• Product Code: MIH
• UDI-Device Identifier: 00613994991171
• UDI-Public: 00613994991171
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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: 01/25/2019
• Device Model Number: ETBF2313C145E
• Device Catalogue Number: ETBF2313C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 06/20/2017; 06/20/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 07/10/2017; 10/04/2017
• 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: Death; Required Intervention
• Patient Age: 86 YR