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

Model Number ETTF2828C70EJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Patient Problem/Medical Problem (2688)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An endurant ii aortic cuff was implanted in a patient for the endovascular treatment of a 68mm abdominal aortic aneurysm.The proximal neck had severe tortuosity.The diameter of the aorta at the renal artery was 25mm.The length of the proximal aortic neck was 40mm.The degree of angulation was 75.It was reported that the stent graft was implanted at just below the left renal artery and approximately 30-50% of the renal artery was covered.Angiography showed that blood flow was secured, however the physician decided to perform percutaneous transluminal renal angioplasty.It was reported that although percutaneous transluminal renal angioplasty was performed, the catheter failed to enter and it was decided to do a postoperative follow up.The physician reported the cause of the event to be anatomy related.No additional clinical sequelae were reported and the patient is being monitored.

Manufacturer Narrative

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

• Brand Name: ENDURANT II EXTENSION 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: 7673106
• MDR Text Key: 113513874
• Report Number: 2953200-2018-00991
• 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
• Report Date: 10/03/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2018
• Device Model Number: ETTF2828C70EJ
• Device Catalogue Number: ETTF2828C70EJ
• Device Lot Number: V06810689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 11/07/2016
• 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: 82 YR