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

Model Number ETLW1616C93E

Device Problems Kinked (1339); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Films review summary: from the returned still image of the endurant ii delivery system, the complaint was confirmed as there was a kink on the graft cover approximately 150mm from the strain relief.The rest of the device appeared unremarkable.The tray and original packaging conditions were not reported.The root cause of the event could not conclusively be determined; however, may be related to shipping as multiple 100% visual inspections of the valiant delivery system exist prior to release and would have detected an issue of this nature had it occurred during production or assembly.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was selected and not used in a patient for treatment of a ruptured 85mm diameter abdominal aortic aneurysm.It was reported that upon removal of the device from the packaging the delivery system was noted to be kinked.The physician attempted to load a guidewire through the device but the wire would not pass the kink.Another endurant ii device was used to treat the patient and the event was resolved.The physician stated the cause of the event could not be determined.No clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 7099272
• MDR Text Key: 95055504
• Report Number: 2953200-2017-01938
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467569
• UDI-Public: 00643169467569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2019
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR