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

Model Number ETLW1620C124E

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Injury (2348); Thrombosis/Thrombus (4440)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 51mm abdominal aortic aneurysm.It was reported that during the index procedure, the main body bifurcate was delivered and deployed on the patients right side of the aorta.The gate was cannulated from the patient's left iliac artery and was deployed.The delivery system was then removed from the left common iliac artery and then a sheath was inserted to achieve hemostasis.The physician noted that some resistance was felt during deployment of the main body bifurcate.Then the physician recaptured the spindle in tapered tip for the delivery system inside the graft and removed it from the right groin.Upon examination of the device it was noted that a wire type object was captured and twisted inside the spindle.After x- rays and examinations it was found that it was a piece of the wire that was frayed from the contra- side (lt).It was confirmed that it was the access wire from the left femoral access.Both delivery systems were intact with no visible defects.Many attempts were made to retrieve the frayed wire that was stuck inside the patient.An open cutdown was performed on the patients rt iliac/ groin to remove the excess frayed wire.The patient also has an open abdominal incision to repair some thrombus that was identified on an intra-operative arteriogram during the procedure.The thrombus was seen and identified in the super mesenteric artery (sma) after the implants were deployed as per the physician the cause of the event cannot be determined.No additional clinical sequelae were provided 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 ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; IE ; 091708096
• MDR Report Key: 10726024
• MDR Text Key: 212713254
• Report Number: 9612164-2020-04076
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467552
• UDI-Public: 00643169467552
• 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: 10/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/23/2020
• Date Device Manufactured: 07/13/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR