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	G32542
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The top cap trigger wire mechanism took severe force to remove.
Event or Problem Description
The top cap trigger wire mechanism took severe force to remove.On 19 may 2017 update : "a lot of force and rotation of the grey positioner at the same time was ultimately what released the trigger wire.It was a fenestrated case and we had to rotate the graft to align it before deploying so when we met resistance the surgeon rotated the grey positioner in reverse and then pulled the trigger wires simultaneously"." we had to rotate the graft significantly to get it back anterior after inserting in to the aorta".
Additional Manufacturer Narrative
'no' because the delivery device was not returned and the graft remains in situ.The work order record for lot ac992100 was reviewed and appeared complete and correct.The device manufacturing instructions provide instructions to correctly insert the bare suprarenal stents into the top cap and the proximal attachment wire.This includes the correct top stent threading, top stent barb positioning, checking that the bare suprarenal stent can move with within the top cap without resistance (to simulate its final deployment), correctly inserting the proximal attachment wire, ensuring that the proximal attachment wire is not kinked at any location or twisted within the graft.The device ifu mentions: "remove the black trigger-wire release mechanism.", followed by "note: if still unable to remove the black trigger-wire release mechanism from the top cap, see section trigger-wire release troubleshooting." "trigger-wire release troubleshooting" provides instructions in sub-section "alternate proximal body deployment." based on the information present, a definitive root cause could not be determined.It is possible that one or a combination of the following factors contributed to the complaint: - wire entanglement within the system - wire jammed within top cap - tortuosity in trigger wire path within the delivery system as stated in the additional information, the graft was rotated to ensure alignment prior to deployment, it is possible that this caused or further caused wire entanglement of the proximal attachment wire.
Event or Problem Description
The top cap trigger wire mechanism took severe force to remove.19 may 2017 update : "a lot of force and rotation of the grey positioner at the same time was ultimately what released the trigger wire.It was a fenestrated case and we had to rotate the graft to align it before deploying so when we met resistance the surgeon rotated the grey positioner in reverse and then pulled the trigger wires simultaneously"."i unfortunately do not have the images anymore so cannot confirm tortuosity." "we had to rotate the graft significantly to get it back anterior after inserting in to the aorta.".

• 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: 6543023
• Report Number: 9680654-2017-00010
• Device Sequence Number: 19116294
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)200321(10)AC992100
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 07/18/2017

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 Model Number: G32542
• Device Catalogue Number: ZFEN-P-2-28-124-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided; 04/28/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 06/13/2017; 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1