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

Model Number	ETLW1610C93E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: e tlw1610c93e, serial/lot #: (b)(4), ubd: 14-aug-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic ulcer of unknown size.It was reported that during the index procedure, the ipsilateral gate of the bifurcate was cannulated instead of the contralateral gate.As a result, both stent graft limbs were implanted in the same gate.The spin test (confirmed spinning the marking catheter) was performed and clearly visualized.The physician then implanted an endurant aui device to seal the bifurcate as treatment and completed a fem-fem bypass.As per the physician, the cause of the event was a procedural step error.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: 9459047
• Report Number: 9612164-2019-05147
• Device Sequence Number: 11221142
• Product Code: MIH
• UDI-Device Identifier: 00643169467606
• UDI-Public: 00643169467606
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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: 08/14/2021
• Device Model Number: ETLW1610C93E
• Device Catalogue Number: ETLW1610C93E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/12/2019
• 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: 69 YR