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

Model Number	ETCF2323C49E
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii aortic extension was implanted in a patient for the endovascular treatment of a penetrating atherosclerotic ulcer (pau) distal to coarctation.The endurant ii aortic extension etcf2323c49e was deployed and the graft opened successfully but the suprarenal stents would not release.It was reported the back end wheel mechanism was functioning.A balloon was inflated within the stents in attempt to release the suprarenal stents.The delivery system was eventually removed, and upon several attempts at ballooning the suprarenal stents, they expanded.The event was resolved.The physician has reported the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II EXTENSION STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7474981
• Report Number: 2953200-2018-00634
• Device Sequence Number: 13796385
• Product Code: MIH
• UDI-Device Identifier: 00613994991423
• UDI-Public: 00613994991423
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: 11/13/2019
• Device Model Number: ETCF2323C49E
• Device Catalogue Number: ETCF2323C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 05/01/2018
• 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: 50 YR