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

Model Number	ETEW2020C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
An endurant ii iliac limb stent graft was implanted in a patient for the endovascular treatment of a mid aorta 33mm penetrating atherosclerotic ulcer (pau).It was reported that after the stent graft was placed it was ballooned with a reliant balloon.Following angio indicated filling of pau still remained, which was a possible type i or type ii endoleak.The physician re-ballooned the stent graft and subsequent angio runs showed a dissection of the aorta with extension into the left renal artery.Several more angio runs were performed and the physician determined the best course of action was to perform post op cta to confirm not rupture.The physician stated the cause of the dissection was ballooning.The cause of the endoleak into the pau is unknown; however, angio shows filling of lumbars prior to filling of pau.No additional clinical sequelae were reported and the patient will be monitored by their physician.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6703938
• Report Number: 2953200-2017-01110
• Device Sequence Number: 10777573
• Product Code: MIH
• UDI-Device Identifier: 00613994991393
• UDI-Public: 00613994991393
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/19/2017

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: 03/14/2019
• Device Model Number: ETEW2020C82E
• Device Catalogue Number: ETEW2020C82E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/11/2017
• 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: 72 YR