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	G32534
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Difficulty was experienced advancing the device into the aorta.The physician unsuccessfully attempted to dilate the iliacs.An attempt to access the iliac limbs from the other side was tried, but it was deemed to be less favourable.A conservative approach was then taken, and the device was removed.Finally, a self-expanding stent was placed in each iliac.Treatment options will be reviewed for further follow up/procedures at a later date.
Additional Manufacturer Narrative
The undeployed device was returned for evaluation.It was observed to be contaminated with biological matter.The inner cannula was noted to be slightly bent.No damage was observed to the dilator tip or any other part of the device.No images were supplied to assist the investigation.Additional information was received that stated the following: the device was not implanted; however, they had trouble while trying to advance it.The procedure was not completed, but the patient did well.The work order for lot: ac1089720 was reviewed and appear complete and correct.The associated inspection records confirms that the device was manufactured to specification.The review of specifications found that there are number of processes and checks in place to ensure that any device deficiency would be identified prior to shipment.The instructions for use (ifu) supplied with the device was reviewed and states the following: access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease, and/or calcification) should be compatible with vascular access techniques and delivery systems of the profile of a 14 french to 22 french vascular introducer sheaths.Iliac conduits may be used to ensure the safe insertion of the introduction system.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization/trauma.Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (> 45 degrees for infrarenal neck to axis of aaa or > 45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<4 mm); greater than 10% increase in diameter over 15 mm of proximal aortic neck length; and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.Irregular calcification and/or plaque may compromise the fixation and sealing of the implantation sites.Necks exhibiting these key anatomic elements may be more conducive to graft migration.Based on the available information, inspection of the returned device and the completed investigation, the root cause was determined to be procedure related; due to patient conditions, the delivery system failed to access the aneurysm site.
Event or Problem Description
Difficulty was experienced advancing the device into the aorta.The physician unsuccessfully attempted to dilate the iliacs.An attempt to access the iliac limbs from the other side was tried, but it was deemed to be less favourable.A conservative approach was then taken, and the device was removed.Finally, a self-expanding stent was placed in each iliac.Treatment options will be reviewed for further follow up/procedures at a later date.

• 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
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: thejus baby ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 13694045
• Report Number: 9680654-2022-00005
• Device Sequence Number: 11810699
• Product Code: MIH
• UDI-Device Identifier: 10827002325347
• UDI-Public: (01)10827002325347(17)241028(10)AC1089720
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 05/04/2022

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 Expiration Date: 10/28/2024
• Device Model Number: G32534
• Device Catalogue Number: ZFEN-P-2-32-94-R
• Device Lot Number: AC1089720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown