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	G32537
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The graft was ordered and correctly built with a scallop at 11:15.The form indicates the scallop is at 1:15.The implanting team was sure it was just a typo however it caused serious concern and distraction preceding implantation of the device.The implanting team could tell by the photos that the device had been built correctly, and the surgeon was highly experienced with zenith fen/branch devices.
Additional Manufacturer Narrative
The complaint device was not returned for evaluation and remains in-situ.Work order (b)(4) was reviewed and appears complete and correct.Manufacturing procedures state: "most common types of information sheets will have a template but for the types of grafts that do not, an existing information sheet can be used for the basis of creating a new one.Delete any information within the document that is not associated with the new information sheet.This would include renaming the title of the document, changing the patient identifier, the lot number (the work order number), the images themselves and the details of the sheath used.For both zfen-p and custom made device information sheets, type in the new patient identifier and lot number and save it under the sub-folder according to its device type and lot number"."for standard and cmd fenestrated grafts there are to be images depicting the following taken: (c) all scallops, fenestrations and sidebranches".The device ifu 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"."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 that the correct device has been selected".The root cause of this event is related to documentation error.The information sheet sent with the device contains a typographical error.The relevant personnel were notified about this complaint and training was conducted.The complaint device was not returned for evaluation and remains in-situ.Work order (b)(4) was reviewed and appears complete and correct.Manufacturing procedures state: "most common types of information sheets will have a template but for the types of grafts that do not, an existing information sheet can be used for the basis of creating a new one.Delete any information within the document that is not associated with the new information sheet.This would include renaming the title of the document, changing the patient identifier, the lot number (the work order number), the images themselves and the details of the sheath used.For both zfen-p and custom made device information sheets, type in the new patient identifier and lot number and save it under the sub-folder according to its device type and lot number"."for standard and cmd fenestrated grafts there are to be images depicting the following taken: (c) all scallops, fenestrations and sidebranches".The device ifu 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"."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 that the correct device has been selected".The root cause of this event is related to documentation error.The information sheet sent with the device contains a typographical error.The relevant personnel were notified about this complaint and training was conducted.
Event or Problem Description
The graft was ordered and correctly built with a scallop at 11:15.The form indicates the scallop is at 1:15.The implanting team was sure it was just a typo however it caused serious concern and distraction preceding implantation of the device.The implanting team could tell by the photos that the device had been built correctly, and the surgeon was highly experienced with zenith fen/branch devices.

• 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: 7106634
• Report Number: 9680654-2017-00026
• Device Sequence Number: 13735775
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)201010(10)AC1004814
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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 Model Number: G32537
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1