MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32534
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The zfen device was used to fix a type 1a endoleak of a previously placed device.There was an issue with the zfen device.It deployed fine, but when trying to dock the grey positioner and top cap, the grey positioner would not advance to meet the top cap.It almost looked like the grey position got caught on a suture or stent/fabric of the first covered seal stent.Several trouble shooting techniques were used with no success.The grey positioner was stuck in the first seal stent.The surgeon had to use a lot of force to pull the grey positioner free.The first endostent was no longer attached to the fabric above the left renal.It is still attached above the right renal.
Event or Problem Description
The zfen device was used to fix a type 1a endoleak of a previously placed device.There was an issue with the zfen device.It deployed fine, but when trying to dock the grey positioner and top cap, the grey positioner would not advance to meet the top cap.It almost looked like the grey position got caught on a suture or stent/fabric of the first covered seal stent.Several trouble shooting techniques were used with no success.The grey positioner was stuck in the first seal stent.The surgeon had to use a lot of force to pull the grey positioner free.The first endostent was no longer attached to the fabric above the left renal.It is still attached above the right renal.
Additional Manufacturer Narrative
The device was not returned for evaluation.Confirmation was received that the patient did not suffer any adverse effect or required any additional procedure due to this event.Medical imaging associate with the complaint was reviewed by william cook australia medical director: "there certainly appears to be an abnormally large gap between main body stents just above the left renal stent, and this would be consistent with a partial detachment of the top endostent from the main graft body at that point.The right side looks normal.There is no video of the attempts to remove the grey pusher from where it caught on the stent, so we can only presume that it caught on a suture or the stent itself.There is a single still image of the top cap being withdrawn down the left side, and the gap between the top stent and the rest of the zfen can also be seen.Unfortunately we don¿t have any extra information that may give any clue as to what exactly was the cause of the pusher catching on the stent." the work order (b)(4) was reviewed and appears complete and correct.There are checks during manufacturing where a non-conforming top cap and grey positioner would most likely be identified.The device ifu states: "advance the grey positioner over the inner cannula until it docks with the top cap.Note: if resistance occurs, slightly rotate grey positioner and continue to gently advance." based on the information present, a definitive root cause for the complaint could not be determined.It is possible that the grey positioner has been caught on a suture or the stent itself during the process of removal due to: - inadequate design of the delivery system, - inadequate instruction to the user, - wrong dimensions, - procedural or patient factors.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 8066943
• Report Number: 9680654-2018-00032
• Device Sequence Number: 1439496
• Product Code: MIH
• UDI-Device Identifier: 10827002325347
• UDI-Public: (01)10827002325347(17)211004(10)AC1024732
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

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: 10/04/2021
• Device Model Number: G32534
• Device Catalogue Number: ZFEN-P-2-32-94-R
• Device Lot Number: AC1024732
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/13/2019
• 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: Other