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

Model Number	ETLW1620C82E
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant ii stent graft was selected and inserted in a patient for the endovascular treatment of a 60mm diameter abdominal aortic aneurysm.The marker pig tail catheter was placed at the flow divider.Retrograde injection was done to mark the take-off of the internal iliac artery.Marks were counted which indicated an 82 length limb should be used.It was reported that when the 82 limb was inserted it was over 1cm short before deployment.The physician felt this was an unacceptable length discrepancy and the device was removed from the patient.A 93 length endurant limb was used instead with no issues.The physician stated the cause of the event was device related (82 limb length was inaccurate).No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the complaint was confirmed; the total length of the stent graft was approximately 79 mm while loaded within the delivery system, which is shorter than indicated on the labelling; however, within manufacturing specification.The stent graft was deployed and confirmed to be the 82 mm total length.The cause of the event was most likely due to the stent graft being loaded within the delivery system, making the length appear shorter than labelled.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6847598
• Report Number: 2953200-2017-01404
• Device Sequence Number: 656089
• Product Code: MIH
• UDI-Device Identifier: 00643169467521
• UDI-Public: 00643169467521
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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: 06/07/2019
• Device Model Number: ETLW1620C82E
• Device Catalogue Number: ETLW1620C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR