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

Catalog Number ZFEN-P-2-26-109

Device Problems Incorrect Measurement (1383); Structural Problem (2506)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

Renal fenestrations were the wrong way round.The discrepancy was discovered days prior to the procedure.The patient had not been admitted to hospital to the procedure at this stage.The graft has now been ordered with the renal fenestrations in the correct location and the procedure is scheduled to take place on the (b)(6).

Event Description

Renal fenestrations were the wrong way round.The discrepancy was discovered days prior to the procedure.The patient had not been admitted to hospital to the procedure at this stage.The graft has now been ordered with the renal fenestrations in the correct location and the procedure is scheduled to take place on the (b)(6).

Manufacturer Narrative

Work order ac1066911 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 'device order form' signed by the physician.There are a number of processes and checks to ensure that all devices are manufactured with fenestrations in the correct location as specified on the device order form.The device ifu states: "fenestrated grafts are made to a customised design to a specification requested by the responsible physician, and are tailored to a specific patient¿s anatomy." based on the information received, the order form signed by the physician contained renal fenestrations that were the wrong way around from the patient anatomy.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: 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: 11024976
• MDR Text Key: 245807613
• Report Number: 9680654-2020-00044
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002381534
• UDI-Public: (01)10827002381534(17)231013(10)AC1066911
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2023
• Device Catalogue Number: ZFEN-P-2-26-109
• Device Lot Number: AC1066911
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other