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	G32546
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Graft deployed.Cannulation of renal arteries done.All 3 trigger wires pulled.Top cap deployed.When trying to go and recapture the top cap, the gray positioner was very difficult to push up thru the graft.With a lot of force, the physician was able to get the gray positioner up to the top cap.The rest of the procedure went as planned.No endoleak seen on final angio.A follow up post ct with no contrast the following day to check the integrity of the graft, and the physician commented one or two of the z-stents looked "unusual" on the ct.The patient was discharged.
Additional Manufacturer Narrative
The device was not returned for evaluation.Medical imaging was supplied and reviewed by the william cook australia medical director: "i can¿t see any fault or failure of the device components, but due to the patient¿s anatomy, and the positioner possibly getting caught under the ¿lip¿ of the stent at the acute backwards angulation, this would be classed as a procedural problem." 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 in the "docking of top cap" section: loosen the pin vise.Secure sheath and inner cannula to avoid any movement of these components.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.Retighten the pin vise and withdraw the entire top cap and grey positioner through the graft and through the sheath by pulling on the inner cannula.Leave the sheath and wire guide in place.A definitive root cause could not be determined from the available information.It is possible that one or more of the following factors may have contributed to the complaint: procedural or patient factors.
Event or Problem Description
Graft deployed.Cannulation of renal arteries done.All 3 trigger wires pulled.Top cap deployed.When trying to go and recapture the top cap, the gray positioner was very difficult to push up thru the graft.With a lot of force, the physician was able to get the gray positioner up to the top cap.The rest of the procedure went as planned.No endoleak seen on final angio.A follow up post ct with no contrast the following day to check the integrity of the graft, and the physician commented one or two of the z-stents looked "unusual" on the ct.The patient was discharged.

• 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: 9067714
• Report Number: 9680654-2019-00031
• Device Sequence Number: 2950467
• Product Code: MIH
• UDI-Device Identifier: 10827002325460
• UDI-Public: (01)10827002325460(17)220722(10)AC1041565
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: G32546
• Device Catalogue Number: ZFEN-P-2-36-107-R
• Device Lot Number: AC1041565
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/15/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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
• Patient Age: 60 YR