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-2-28-109-R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
During a fenestrated abdominal aortic aneurysm procedure, while still sheathed, the markers for anterior/posterior appeared to be off to one side which caused some confusion.
Additional Manufacturer Narrative
The complaint device was not returned for evaluation, and remains in-situ.The photos taken during manufacture of the graft as made and loaded were reviewed, and it appeared that the complaint device was manufactured as per specification.The screenshots of the imaging received were reviewed.The screenshots show a portion of the sheathed proximal portion of the complaint device (the portion of the graft visible is between the bare suprarenal stent to anterior and posterior markers).It was observed that when the graft is within the sheath, the anterior and posterior gold markers do not clearly form a '+' sign, and are not in the centre of the sheath.The work order record for ac983509 was reviewed and appeared complete and correct.There are processes and checks during manufacturing that would most likely identify nonconforming anterior and posterior gold markers: "stitch 3 long gold markers vertically (i) on the 12 o¿clock pencil line.The total length of the 3 markers is 10mm [+-1mm]." and "this o¿clock position may be required close to a stent strut, in which case the vertical line could cross over the stent strut when gold markers are positioned." "stitch 3 small gold markers horizontally (---) at the 6 o¿clock position 3mm [+/- 1mm] apart.Compress the graft together to find this position and mark.These markers must line up with the middle anterior marker.This six o¿clock position may or may not fall within the gathered stent struts." "this o¿clock position may be required close to a stent strut or within the gathered material in the reducing ties.In this case the horizontal line could cross over the stent strut when the gold markers are positioned." "compress the graft together at this stage to ensure the markers have formed a centred cross (+).Readjust gold marker positioning if markers don¿t form a centred cross." "smear a small amount of loctite 4981 on the external thread of the handle main body.Align the distal gold marker with the dimples in the handle main body." "with a digital camera, capture an image of the graft as made and loaded including anterior markers." "slide a corresponding size vsplv (peel-away sheath), flared end first, over the tip of the ossa (one-shot subassembly).Symmetrically compress each stent on the graft and ensure the distal attachment wire is held straight against the cannula while sliding the vsplv over each stent until the entire graft is compressed and the buffed tip of the vsplv is resting on the non-tapered part of the ossa tip." "fenestrated grafts have an extra bulkiness to their structure.These features increase the risk of the sheath being damaged.Extra care needs to be taken when compressing each stent, with gold markers and large knots." "holding the vsplv and the captor valve together with one hand, slide the ossa into the sheath assembly until about 10mm of the 0.018" wire is visible in the top cap.Do not twist the sheath after transferring.Pull the vsplv backwards out of the captor valve.The tip of the sheath should fit snugly on the tip of the ossa." "check the 3 anterior long gold markers are positioned vertically on the 12 o¿clock line.Using a metal ruler check the total length of the markers is 10mm [±1mm].Using a metal ruler check that the first gold marker measures 8mm [+2/-0] down from the bottom of the lowest fenestration gold marker.Gold markers should be attached with double loops and four locking knots." "the o¿clock position may require the markers to be placed close to a stent strut, in which case the vertical line could cross over the stent strut when gold markers are positioned." "check the 3 posterior small gold markers are positioned horizontally at the 6 o¿clock position.Using a metal ruler check the markers are positioned 3mm [±1mm] apart." "the o¿clock position may require the markers to be placed close to a stent strut, in which case the horizontal line could cross over the stent strut when gold markers are positioned." "compress graft together to find 6 o¿clock position, these markers must line up with the middle anterior gold marker to form a centred cross (+).Gold markers should be attached with double-loops and four locking knots." the ifu instructs to verify the orientation of the graft prior to insertion, and prior to releasing the graft; the ifu also instructs to rotate all components of the system together to avoid any twist of the graft: "the proximal body graft also has vertically-aligned gold markers on the anterior side (at the 12:00 o¿clock position) that should form a cross (+) with the horizontally aligned gold markers on the posterior side (180 degrees opposite the vertical markers) when the device is properly oriented." "to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula)." "before insertion, position proximal body delivery system on patient¿s abdomen under fluoroscopy to assist with orientation and positioning.Rotate to a position where the anterior markers are situated in the most anterior (12:00 o¿clock) position.The sidearm of the hemostatic valve may serve as an external reference to the fenestration(s) and/or scallop(s), anterior and posterior markers and body side markers." "verify position of the wire guide in the thoracic aorta.Ensure that fenestration(s) and/or scallops are at the level of the appropriate arteries and the anterior markers are in the most anterior (12:00 o¿clock) position." "the vertical anterior markers, and the horizontal posterior markers should form a cross, on the fluoroscopic image, when correctly oriented." "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." based on the information present, a definitive root cause could not be determined.It is possible that one or more of the following factors contributed to the complaint: - operator error, such as the graft was not uniformly compressed during loading.- operator error, such as the graft was twisted during loading.- user technique, such as manipulation of delivery system during insertion caused twisting.The complaint confirmed that the graft deployed as intended with no complications and that the patient did not experienced any adverse effects.
Event or Problem Description
During a fenestrated abdominal aortic aneurysm procedure, while still sheathed the markers for anterior/posterior appeared to be off to one side which caused some confusion.

• 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: 6153387
• Report Number: 9680654-2016-00018
• Device Sequence Number: 415139
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)191014(10)AC983509
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/13/2017

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-2-28-109-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO DETAILS PROVIDED.
• Patient Age: 89 YR