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

Model Number	ETBF2516C166E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was confirmed; there was a break in the screwgear.The root cause of the event could not be conclusively determined; however, was likely due to damage during shipping and/or receiving.The break was in the minor thread region of the screwgear, which may have been overlooked during initial inspection of the device.Film evaluation summary: the exact cause of screwgear minor thread damage cannot be conclusively determined from the pre-implant 3d recon report and the still photo returned.The image of the original packaging was not provided.It was unclear if there was shipping/handling damage to the original packaging that could potentially contribute to the event.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 6.2 cm in diameter abdominal aortic aneurysm.It was reported that during the implant procedure the endurant stent graft body deployed and when the thumb wheel was going to be turned to release the suprarenal struts the back-end was broken and separated from the rest of the deployment handle.The physician deconstructed the handle and manually deployed the tip capture release and the stent graft was successfully deployed.The physician cannot determine the cause of the event.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Corrected information: date of birth.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: 6393122
• Report Number: 2953200-2017-00355
• Device Sequence Number: 798046
• Product Code: MIH
• UDI-Device Identifier: 00613994991270
• UDI-Public: 00613994991270
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2017

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: 07/07/2018
• Device Model Number: ETBF2516C166E
• Device Catalogue Number: ETBF2516C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided; 03/20/2017; 03/20/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/13/2017; 09/29/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 110