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	G32531
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The renals were at the wrong (swapped) levels; left and right were at different points than they needed to be.The procedure could not proceed as device is custom fitted.Procedure is rescheduled for when replacement graft is delivered so hasn't been done yet.
Additional Manufacturer Narrative
The device was returned for investigation.Measurements were taken of the fenestrations in order to compare with the fenestration layout used during manufacturing, as well as the charts approved by the physician.Based on these measurements, it can be concluded that the graft was manufactured according to the fenestration layout used during manufacturing, as well as the charts approved by the physician.Work order ac1044611 was reviewed and appears complete and correct.Upon reviewing the photos taken of the complaint device during manufacture it appears that the device was manufactured as per the 'charts approved' form signed by the physician.The device ifu states: "each patient must be evaluated on an individual basis to determine the specific location of the graft fenestrations (refer to planning and sizing sheet), with careful consideration also given to both the potential benefits and specific risks associated with the procedure." "the proximal body graft may contain up to three precisely located holes (fenestration(s)), and cut-outs from the proximal margin (scallop(s)) of the graft material.The fenestration and/or scallop locations are individualized to the patient anatomy based on measurements from high resolution pre-operative ct imaging.Refer to the planning and sizing sheet for information regarding how these locations are determined." "verify from pre-implant planning (refer to planning and sizing sheet) that the correct device has been selected." from the sizing sheet it can be seen that the two small fen's had opposite clock positions vs.Distance from proximal edge when compared to the charts approved/fen layout.This indicates that there may have been a mix up during the planning stage of this device.
Event or Problem Description
The renals were at the wrong (swapped) levels; left and right were at different points than they needed to be.The procedure could not proceed as device is custom fitted.Procedure is rescheduled for when replacement graft is delivered so hasn't been done yet.

• 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: 9318164
• Report Number: 9680654-2019-00046
• Device Sequence Number: 2578992
• Product Code: MIH
• UDI-Device Identifier: 10827002325316
• UDI-Public: (01)10827002325316(17)220910(10)AC1044611
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 09/10/2022
• Device Model Number: G32531
• Device Catalogue Number: ZFEN-P-2-26-94-R
• Device Lot Number: AC1044611
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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