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

Model Number ETBF2313C166E

Device Problems Difficult to Insert (1316); Kinked (1339); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

Eighteen-failure to follow instructions (attempt to use a damaged device).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 Description

An endurant ii stent graft system was attempted to be implanted in the patient for the endovascular treatment of a 58 mm in diameter abdominal aortic aneurysm.It was reported that, during the index procedure, the device was inspected and discovered to have a crease in the graft cover.The box of the device was inspected and discovered to be bent.The physician elected to attempt to use the device.However, when attempting to insert the device through another manufacturer's 18fr sheath, the graft cover became bent along the crease and could not be inserted.The physician attempted to insert the device through the sheath again with the same result.The physician then elected to use another device and the procedure was completed without any complications.Per the physician, the cause of the event was likely attributed to damage to the packaging.No sequelae were reported and the device never entered the patient.

Manufacturer Narrative

Device evaluation results are: the kink event was confirmed as kinks were noted on the distal end of the graft cover.The cause of the event could not be conclusively determined however, as it was reported that there was damage to the original packaging, shipping/handling may have contributed to the out of the box kink.The reported insertion difficulty could not be confirmed as the other manufacturer's sheath was not returned for analysis however, the out of the box kink most likely contributed to the insertion difficulty through the sheath resulting in multiple kinks on the graft cover.

Manufacturer Narrative

Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 6028902
• MDR Text Key: 57449266
• Report Number: 2953200-2016-01801
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2018
• Device Model Number: ETBF2313C166E
• Device Catalogue Number: ETBF2313C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1