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	G32538
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The device was built incorrectly.The dimensions did not match the specifications on the order form.Upon inspection of the graft and comparison of the e#, it was noticed after looking at the paperwork in the box for the graft that the fenestrations that were requested by the physician on the order form were not the ones that were on the paperwork in the box.The case was paused.The information was cross referenced with the surgeon and it was confirmed that the healthcare facility did not receive a graft with the makeup that was requested.The case was then cancelled.
Additional Manufacturer Narrative
The device was returned for evaluation.The device was inspected prior to graft deployment and no non-conformances were identified.The graft was deployed and inspected for size and position of scallop/fenestrations.During visual inspection it was confirmed that the device was manufactured according to the work order ac1022385 and the 'fen layout' attached to the work order.Work order ac1022385 was reviewed and appears complete and correct.Upon review of the physician order form and the fenestration layout attached to the work order it was confirmed that the incorrect fenestration layout was selected.The device ifu states: "inspection prior to use inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to your cook representative or your nearest cook office.Prior to use, verify correct devices (quantity and size) have been supplied for the patient by matching the device to the order prescribed by the physician for that particular patient." this is the first complaint of this type that was received.A non conformance record was opened and as a consequence an update to ensure confirmation of product code and patient identifier (or name) was done to appropriate procedures.
Event or Problem Description
The device was built incorrectly.The dimensions did not match the specifications on the order form.Upon inspection of the graft and comparison of the e#, it was noticed after looking at the paperwork in the box for the graft that the fenestrations that were requested by the physician on the order form were not the ones that were on the paperwork in the box.The case was paused.The information was cross referenced with the surgeon and it was confirmed that the healthcare facility did not receive a graft with the makeup that was requested.The case was then cancelled.

• 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: 7972030
• Report Number: 9680654-2018-00029
• Device Sequence Number: 1755371
• Product Code: MIH
• UDI-Device Identifier: 10827002325385
• UDI-Public: (01)10827002325385(17)210816(10)AC1022385
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 08/16/2021
• Device Model Number: G32538
• Device Catalogue Number: ZFEN-P-2-30-109-R
• Device Lot Number: AC1022385
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1