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	11/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The white wire trigger mechanism would not release.The physican was able to complete the procedure with the complaint device successfully.
Additional Manufacturer Narrative
A portion of the delivery system was returned for evaluation; the release mechanisms and sheath were not returned.The following observations were made: - the flexor sheath assembly and release mechanisms were not returned.- there was biological matter on the delivery system.- there was a score on the pusher tip crossing both lumens and creating a spiral path around the pusher, the score appears to originate from the right lumen where the distal attachment wire enters the pusher.- there was deformation of the distal attachment hole.The deformation is an elongation of the hole and is longitudinal to the delivery system and then almost perpendicular.- scratches were present on the handle when the trigger wires exit the handle, and on the posterior side (opposite to where the trigger wires exit the handle) - there was deformation of the hole where the trigger wires exit the handle.The hole is manufactured as an ellipse and the deformation is a sharp apex at the curve most proximal.The work order record for ac982822 was reviewed and appeared complete and correct.Manufacturing instructions state: "insert the distal end of the 0.013" wire into the angled hole of a white release mechanism and place it over the handle main body whilst ensuring the 0.018" and 0.013" nitinol wires are located within the white release and aligned to the flat side of the handle main body.Secure with a release mechanism thumb screw." "a quality control inspector performs an in-process inspection at this stage, gauging the deployment system for correct size.Gauge and check the positioning of the wires.A visual observation of the 0.013" being retracted into the graft is required.Retract the 0.013" wire by attaching the needle holder to its distal end and dragging the wire until about 15 mm judgement is left out of the tip of the pusher.The qc inspector will now sign the required stamps to confirm the checks." "place the ossa (one-shot subassembly) onto the offset style manual grub screw pusher, lining up the threaded endhole of the white release mechanism with the pin on the slider." "place a m3 x 8 mm grub screw onto the pin and activate the offset style manual grub screw pusher anchoring the grub screw within the release mechanism.Remove the ossa and trim the wire in the sidehole flush with the release mechanism." "insert the grub screw depth gauge into the end hole where the grub screw is anchored and confirm correct depth of the grub screw by ensuring the end of the release mechanism is within the etch mark of the depth gauge." additional information was requested and received: - the screw on the release mechanism was easily removed.- the release mechanism was "removed totally off the handle but was not attached to the wire.It did come off the handle".- "the wire actually broke at the hub of wire release mechanism" - "the white handle was dismantled, the trigger wire was found and retrieved using a mosquito clamp" and "once the handle was taken apart the wire was remove with a clamp and still had tension." in the additional information received, it was stated that the patient expired two months after the procedure, the physician stated that the patient had post-operation renal failure but did not believe that this was related to device issues.The complaint reported that the physician completed the procedure with the complaint device successfully.Therefore, based on the information present, there is no evidence that the device complaint ("white trigger mechanism would not release" and "[release mechanism] was removed totally off the handle but was not attached to the wire") contributed to the patient death.Based on the information present, a definitive root cause could not be determined.It is possible that the one or a combination of the following contributed to the complaint: - operator error, the distal attachment wire was not captured or was partially captured by the release mechanism - user technique, pulling of the release mechanism and partially captured wire cause the wire to break at the release mechanism.It is possible that the scores on the pusher tip and deformed distal attachment hole was caused by the tension applied to the distal attachment wire during the manual retrieval of the wire.It is possible that the spiral path of the scores on the pusher tip and the deformation of the distal attachment hole on the pusher tip were caused by movement of the slackened distal attachment wire during loading and sheathing of the graft.
Event or Problem Description
The white wire trigger mechanism would not release.The physician was able to complete the procedure with the complaint device successfully.

• 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: 6128206
• Report Number: 9680654-2016-00016
• Device Sequence Number: 16432786
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)191004(10)AC982822
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/03/2017

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-2-28-124-R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2016
• Supplement Report FDA Received Date: 02/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1