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	G32532
Health Effect - Clinical Codes	Paralysis (1997); Paraplegia (2448)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced an embolic event and woke up paralyzed, one day post treatment with a fenestrated device.
Additional Manufacturer Narrative
The device was not returned for evaluation.No imaging was obtained to assist with the investigation.The work order for the lot ac1093890 was reviewed and appear complete and correct.The associated inspection records confirms that the device was manufactured to specification.The instructions for use (ifu) supplied with the device states the following: fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.Systemic anticoagulation should be used during the implantation procedure based on hospital and physician preferred protocol.If heparin is contraindicated, an alternative anticoagulant should be considered.The physician and patient (and/or family members) should review the risks and benefits when discussing this fenestrated endovascular device.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.4.3 implant procedure: take care during manipulation of catheters, wires and sheaths within an aneurysm.Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization.Embolization (micro and macro) with transient or permanent ischemia or infarction and neurologic local or systemic complications and subsequent attendant problems (e.G., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis) are listed as potential adverse events.The risk document for zenith fenestrated aaa endovascular graft (us) was updated under change order to include the potential failure mode of "procedural complications" and the effect of failure of "spinal cord ischaemia" amongst other potential effects of failure.Based on the available information and the completed investigation, a definitive root cause for the event was not able to be determined.However, the most likely root cause for the reported adverse event is procedural complications, not related to the design or manufacturing process of the device.The ifu provided with the graft outlines embolization and neurologic local or systemic complications and subsequent attendant problems (e.G., paraplegia) as potential adverse events.
Event or Problem Description
The patient experienced an embolic event and woke up paralyzed, one day post treatment with a fenestrated device.

• 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: 13694072
• Report Number: 9680654-2022-00004
• Device Sequence Number: 19989438
• Product Code: MIH
• UDI-Device Identifier: 10827002325323
• UDI-Public: (01)10827002325323(17)250118(10)AC1093890
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2025
• Device Model Number: G32532
• Device Catalogue Number: ZFEN-P-2-28-94-R
• Device Lot Number: AC1093890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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: Disability
• Patient Age: 66 YR
• Patient Sex: Male