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

Model Number ETLW1620C82EJ

Device Problems Inability to Irrigate (1337); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft system was implanted in a patient for the endovascular treatment of a 6.0cm abdominal aortic aneurysm.It was reported that during the index procedure an attempt was made to flush the guidewire lumen in preparation of the delivery system.Flushing could not be performed.As the customer felt it was unsafe, the product was not used.As per the physician the cause of the event cannot be determined.Another device was used.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received for this case: during the index procedure the guidewire was replaced with a stiff one, and the clog was cleared device evaluation summary; a kink was observed on the graft cover at the distal end of the stent stop.The guidewire lumen was successfully flushed with no residue observed exiting from the lumen.The stent graft was deployed in-vitro with no issues noted.A kink was observed on the inner member at the distal end of the stent stop.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received for this case: the delivery system was inserted a little into the patient, but use was discontinued to prioritize patient¿s safety when resistance was felt.No foreign material was noted after the clog was cleared using a stiffer guidewire and no kink was observed when the device was removed from the patient.No shipping/packaging issues were observed prior to using the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7316267
• MDR Text Key: 101631116
• Report Number: 2953200-2018-00316
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 06/14/2019
• Device Model Number: ETLW1620C82EJ
• Device Catalogue Number: ETLW1620C82EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 05/11/2018; 05/11/2018; 05/29/2018; 06/20/2018; 08/08/2018
• Supplement Dates FDA Received: 05/22/2018; 05/25/2018; 06/05/2018; 08/08/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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: 86 YR