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-2-28-124-R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Upon removing the black trigger wire safety for the top cap, it deployed the top cap.The pin vice was still tightened.The case was able to be completed.
Additional Manufacturer Narrative
The device was not evaluated because it was not returned to manufacturer.The work order record for batch ac977138 was reviewed and appeared complete and correct, and review of the complaint device's photos taken during manufacture concluded that the endovascular graft was manufactured as per specification.The procedural imaging was reviewed and it was noted that the device appeared to be manufactured to specification with the bare suprarenal stent adequately captured within the top cap.There are processes and checks during manufacturing that ensure that the bare suprarenal top stent is securely attached within the top cap."hold the 0.013" and 0.018" wires away and pull the points into the top cap until the stent loop points are visible through the bevelled hole in the top cap.Slide the stent loading tool over the distal end of the graft and over the ossa.Carefully move the spiked stent back and forth about 5mm ¿ 10 mm within the top cap to partially simulate its final deployment, testing for any possible resistance." the ifu states "verify proper position of proximal body.Remove the safety lock from the first (distal) gold trigger-wire release mechanism.Withdraw and remove the trigger-wire by sliding the gold trigger-wire release mechanism off the handle and then remove via its slot over the inner cannula" "remove the safety lock from the top stent trigger-wire release mechanism.Under fluoroscopy, withdraw and remove the trigger wire to unlock the suprarenal stent from the top cap by sliding the black trigger-wire release mechanism off the handle and then remove via its slot over the inner cannula." "loosen the pin vice.Control the position of the graft by stabilizing the grey positioner of the introducer." "caution: before deployment of the suprarenal stent, verify that the position of the access wire extends just distal to the aortic arch.Ensure that the dilator tip will not extend beyond the end of the access wire guide during advancement, and if required re-position the access wire guide into the aortic arch to accommodate." "deploy the suprarenal stent by advancing the top cap inner cannula 1 to 2 mm at a time while controlling the position of the proximal body until the top stent is fully deployed.Advance the top cap cannula an additional 1 to 2 cm and then retighten the pin vice to avoid contact with the deployed suprarenal stent." based on the information present, a definitive root cause could not be determined.It was concluded that the premature deployment of the top cap could have resulted from one of the two possible root causes: it is possible that the loading of the graft into the sheath (28mm in a 20fr) caused the graft to be pulled under tension allowing it to be compressed into the 20fr sheath (inner diameter approximately 6.7mm).During release of the proximal attachment, the release of the tension on the graft could cause the graft to contract, thus resulting in a premature deployment of the topcap.It is possible that there was bowing of cannula at the site of the graft deployment (as seen in the imaging), and during release of the proximal attachment, this caused the cannula to straighten out, thus resulting in a premature deployment of the top cap.(b)(4).Appropriate personnel will continue to monitor for similar events.
Event or Problem Description
Upon removing the black trigger wire safety for the top cap, it deployed the top cap.The pin vice was still tightened.The case was able to be completed.

• 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: 5881039
• Report Number: 9680654-2016-00006
• Device Sequence Number: 18980713
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)190629(10)AC977138
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2016

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-2-28-124-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2016
• Supplement Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR