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

Model Number	G32577
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient of undisclosed age underwent a fenestrated aortic aneurysm repair in which the zenith fenestrated aaa endovascular graft proximal body (g32537) and the distal bifurcated body (g32577) was used.There had been two fenestrated procedures scheduled for the same day.It was noted after the first procedure that the incorrect grafts had been placed in the wrong patient.It was reported that the patient was doing well and the grafts were working as they were close to the size needed and ordered for this patient.
Event or Problem Description
A male patient of undisclosed age underwent a fenestrated aortic aneurysm repair in which the zenith fenestrated aaa endovascular graft proximal body (g32537) and the distal bifurcated body (g32577) was used.There had been two fenestrated procedures scheduled for the same day.It was noted after the first procedure that the incorrect grafts had been placed in the wrong patient.It was reported that the patient was doing well and the grafts were working as they were close to the size needed and ordered for this patient.
Additional Manufacturer Narrative
No product was available for evaluation.No imaging was supplied for evaluation.Additional information was received "the procedure for the second patient was rescheduled for november and new grafts were ordered.¿ the relevant work order was reviewed and appeared complete and correct.No non conformances were recorded in the work order.The labels were reviewed and appear complete and correct with no notable abnormalities.Review of specifications found sufficient instructions and checks to ensure each device is correctly labelled.Each custom-made device is given a unique identifier which is associated with the charts approved and doctors request forms.The instructions for use (ifu) supplied with the complaint device (ifu-fu/3) states "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." from the information provided an exact root cause could not be determined, however one or more of the following could have contributed to the reported issue: -insufficient information on labels; or -procedural errors.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 12503089
• Report Number: 9680654-2021-00018
• Device Sequence Number: 4094554
• Product Code: MIH
• UDI-Device Identifier: 10827002325774
• UDI-Public: (01)10827002325774(17)240407(10)AC1077638
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 04/07/2024
• Device Model Number: G32577
• Device Catalogue Number: ZFEN-D-12-62-76-C
• Device Lot Number: AC1077638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male