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

Model Number	ETTF3232C70E
Medical Device Problem Codes	Difficult to Remove (1528); Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
An aneurx stent graft system was implanted in the patient for the endovascular treatment of a 63 mm in diameter abdominal aortic aneurysm.The patient was lost to follow up.Two endurant cuffs were implanted during intervention.It was reported that the patient returned for follow up and it was discovered that the aneurx stent graft had migrated and had a proximal type i endoleak.The physician elected to implant a 32x32x70 endurant aortic cuff, however while attempting to recapture the tip of the delivery system after deployment of the aortic cuff the physician unintentionally pushed the graft cover up and caused the distal end of the cuff to prolapse proximally.The physician then implanted an additional 32x32x49 endurant aortic cuff but was unable to obtain sufficient overlap for a seal.The physician attributed the lack of overlap to the removal issues due to the patient's anatomy and the severely angled neck (anterior and posterior) where the tapered tip was dragging against the first cuff.In addition, the proximal portion of the aneurx bifurcated stent graft was under 3cm in length and was bent due to the angle of the neck making the seating for the second cuff very difficult.The physician then elected to convert the patient to open repair.Per the physician, the cause of the migration resulting in the proximal type i endoleak was due to disease progression.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6227084
• Report Number: 2953200-2017-00022
• Device Sequence Number: 16159288
• Product Code: MIH
• UDI-Device Identifier: 00613994991508
• UDI-Public: 00613994991508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2016

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: 08/11/2018
• Device Model Number: ETTF3232C70E
• Device Catalogue Number: ETTF3232C70E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 76 YR