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

Model Number	ETCF2525C49E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 50 mm diameter abdominal aortic aneurysm.The length of the proximal aortic neck was 8 mm, with a diameter of 18 mm at the renal artery.The angulation was 45 degrees.Moderate vessel tortuosity and mild vessel calcification was present.It was reported that during the index procedure, upon deployment of the suprarenal stent, the delivery system "thumbwheel" broke.The physician stated that while dealing with the broken thumbwheel, the implanted device slipped down from the target landing zone.An angiogram then revealed a type i endoleak.A proximal cuff was then implanted and the type i endoleak was resolved.It was reported that a follow-up ct scan the next day showed that both of the renal arteries were covered by the proximal cuff.A secondary intervention was then performed, with bilateral renal stents successfully implanted to restore flow.As per the physician, the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Failure to follow instructions (aortic neck length less than 10 mm and diameter less than 19 mm).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8882707
• Report Number: 9612164-2019-03321
• Device Sequence Number: 2730876
• Product Code: MIH
• UDI-Device Identifier: 00613994991430
• UDI-Public: 00613994991430
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 03/05/2021
• Device Model Number: ETCF2525C49E
• Device Catalogue Number: ETCF2525C49E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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: 71 YR