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
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It appears that the large fenestration built for 12:00 position is closer to 12:15 or 12:30 in relation to the 12:00 vertical anterior marker.The discrepancy was enough that the doctor decided to go back in and cannulate/stent the superior mesenteric artery (sma) to correct the miss-alignment.In the attached ap image, it¿s appears that the sma ostium outline is off to the right of the large fenestration.
Additional Manufacturer Narrative
The graft remains in situ and therefore cannot be returned for evaluation.Work order (b)(4) was reviewed and appears complete and correct.The device order form signed by the physician was compared to the fen layout and work order, which contains the fenestration layout and photographs during manufacture and found to align.There are a number of processes and checks in place to ensure that the fenestration placement and dimensions are manufactured as per the device order form signed by the physician.From the information provided in the complaint it is difficult to determine a definitive root cause, there is no evidence to indicate that the device was not manufactured according to the signed order form.It is possible that one or more of the following factors may have contributed to this complaint: fenestrations planned in incorrect positions.Implant sizes incompatible with anatomy.Changes in patient anatomy between time of planning and procedure caused.Misalignment of fenestration position.Procedural factors.Patient factors.
Event or Problem Description
It appears that the large fenestration built for 12:00 position is closer to 12:15 or 12:30 in relation to the 12:00 vertical anterior marker.The discrepancy was enough that the doctor decided to go back in and cannulate/stent the superior mesenteric artery (sma) to correct the miss-alignment.In the ap image, it appears that the sma ostium outline is off to the right of the large fenestration.

• 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: 10637041
• Report Number: 9680654-2020-00031
• Device Sequence Number: 11503945
• Product Code: MIH
• UDI-Device Identifier: 10827002325385
• UDI-Public: (01)10827002325385(17)230821(10)AC1064492
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: G32538
• Device Catalogue Number: ZFEN-P-2-30-109-R
• Device Lot Number: AC1064492
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/08/2020
• 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: Required Intervention
• Patient Age: 74 YR