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-2-34-107-R
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The graft layout specified that the scallop was 8 mm deep.Device order form was ordered as a 12 mm deep scallop.Due to this, the physician had to deploy the graft on the back table to confirm the measurement prior to implant.The graft was built with a 12 mm scallop and this measurement was confirmed by the physician; however the paperwork was incorrect as it indicated a 8 mm scallop.
Additional Manufacturer Narrative
The complaint device was not returned for evaluation, and remains in-situ.Additional information was received: "the original order form stated a 12 mm deep scallop but the fenestration layout stated a 8 mm deep scallop.Dr.Vasquez had to deploy the graft on the backtable and confirm it was 12 mm deep.The layout provided by cook was incorrect even though the graft was built correctly." the work order record for ac986235 was reviewed: - the fenestration layout specifies a scallop height of 12 mm.- the fenestration information sheet (fis), which contains the 'as made and loaded' photos of the finished graft, documents the scallop height as 8 mm.The 'device order form' signed by the physician, and the fenestration layout drawing used for manufacture both specify a scallop height of 12 mm.There are a number of processes and checks that would most likely identify an incorrectly sized scallop and an fenestration information sheet: "confirm that the height, width, diameter, distance from the edge and/or o¿clock position for each fenestration/scallop on the signed device order form matches the table on the fenestration layout drawing." "stamp both fenestration layout drawings supplied with an ¿in-process qc check¿ stamp.Fill in stage line with ¿fen layout¿ and then sign and date." "use a metal ruler to measure the fenestration and/or scallop marking dimensions on the graft material as per the fenestration layout drawing attached to the work order.A pencil line should be drawn on the graft material at 12:00." "using a metal ruler, measure the fenestration and/or scallop marking dimensions on the graft material as per the fenestration layout drawing." "verify that the following information on the photos produced by manufacturing is correct: product code; lot number; fenestration positioning as per fenestration layout drawing.Stamp work order with 'in process' stamp.Sign fis check." note: a scallop is defined as a fenestration, and therefore this instructions includes the qc check that the scallop information is correct."visually check the in-process stamp is signed for fis check." the instructions for use (ifu) mentions: "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 information sheet (fis) was reviewed and it is evident that the scallop height was incorrectly documented as 8 mm.Capa (b)(4) quality control inspections was opened on 26 may 2015 to address inadequacies in-process qc inspections.This capa is currently in the 'implementation' stage and is due for completion on the 31 may 2017.Appropriate qc procedure will be updated as part of this capa's actions and will include clarification to the qc inspection for the positioning and size of fenestrations and scallops to be checked.
Event or Problem Description
The graft layout specified that the scallop was 8 mm deep.Device order form was ordered as a 12 mm deep scallop.Due to this, the physician had to deploy the graft on the back table to confirm the measurement prior to implant.The graft was built with a 12 mm scallop and this measurement was confirmed by the physician; however the paperwork was incorrect as it indicated a 8 mm scallop.

• 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: 6303089
• Report Number: 9680654-2017-00002
• Device Sequence Number: 10994259
• Product Code: MIH
• UDI-Device Identifier: 10827002325453
• UDI-Public: (01)10827002325453(17)191206(10)AC986235
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/22/2017

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 Catalogue Number: ZFEN-P-2-34-107-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2017
• Supplement Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR