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

Model Number	ETLW1610C199E
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the reported inability to advance the limb when attempting to load the device into the sheath and resulting bent tip could not be determined from the pre-implant films provided.Images during implant were not returned and the reported event could not be assessed, and ct¿s post-implant were also not available for return.Review of pre-implant ct¿s confirmed that the patient had a 53mm max diameter infrarenal aaa, as well as aneurysmal right and left common iliac arteries.The calcified distal aorta was 20mm in diameter, and the iliac arteries were moderately tortuous and extensively calcified; bilaterally.Other than the calcified distal aorta and iliac arteries, analysis of the returned films did not reveal any anatomical characteristics that could explain the reported event.Analysis of the device could not be performed since not available for return; thereby limiting the extent of the analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was planned for implantation in a patient for the endovascular treatment of a 53mm abdominal aortic aneurysm.During the index procedure the physician claimed that the endurant ii limb would not advance when attempting to load the device into a 16f sentrant sheath and noted that the tip of the device was bent.The physician claims that the endurant ii limb delivery system was defective.A shorter length endurant ii limb was used during the index procedure to resolve the event.No additional clinical sequelae were reported and the patient is fine.

• 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: 7424567
• Report Number: 2953200-2018-00537
• Device Sequence Number: 19140903
• Product Code: MIH
• UDI-Device Identifier: 00643169467620
• UDI-Public: 00643169467620
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 04/12/2018

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: 09/19/2019
• Device Model Number: ETLW1610C199E
• Device Catalogue Number: ETLW1610C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88