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

Model Number	ETUF3214C102E
Medical Device Problem Codes	Malposition of Device (2616); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Occlusion (1984); Renal Failure (2041)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii aui stent graft system was implanted in a patient for the endovascular treatment a 5.5 cm in diameter abdominal aortic aneurysm.It was reported that during the initial procedure the physician elected to perform a snorkeling of the renal arteries.The endurant aui was implanted (intentionally oversized, to accommodate the snorkeling procedure) and another manufacturer¿s stent graft was inserted into the renal artery for snorkeling and deployed.The patient has three renal arteries; two main renal arteries and an accessory renal artery on the left side distal to the left main renal artery.The physician snorkeled the left accessory renal artery.Upon removal of another manufacturer¿s sheath, the sheath cover was caught on the endurant aui suprarenal anchoring pin.The physician pulled on the sheath to release it, and the endurant aui was pulled proximally, covering all three renal arteries.After failed attempts to bring the aui more distal and failed attempts to cannulate the renal arteries with a wire for stenting, the physician completed deployment of the aui distal extension.Upon removal of the other manufacturer¿s sheath it was noted that a piece of the other manufacturer¿s sheath remained in the patient.The tip of the of the other manufacturer¿s delivery system, was also caught on the endurant aui anchoring pin and broke off, leaving a piece of the tip in the patient.The physician opened the patient to perform a renal bypass.The day after surgery, the patient was still intubated on pressors and in renal failure.Per the physician, the exact cause of the event cannot be determined, however it may be related to the patient¿s anatomy.No additional clinical sequelae were reported and the patient is being monitored by their physician.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6586525
• Report Number: 2953200-2017-00846
• Device Sequence Number: 16166011
• Product Code: MIH
• UDI-Device Identifier: 00643169232617
• UDI-Public: 00643169232617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/28/2017

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: 07/12/2017
• Device Model Number: ETUF3214C102E
• Device Catalogue Number: ETUF3214C102E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: Required Intervention
• Patient Age: 78 YR