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	G32533
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	03/05/2018
Type of Reportable Event	Death
Event or Problem Description
The device was placed successfully.While cannulating, the wire (boston scientific wire) went out too far into the renal artery and perforated the renal artery.The device user attempted to control the bleeding and believed the patient was hemodynamically stable.The procedure continued and 3 additional grafts were placed successfully.
Additional Manufacturer Narrative
The complaint device was not returned for evaluation.Three requests were made for additional information and for medical imaging.No response was received.Work order (b)(4) was reviewed and appears complete and correct.Cook medical (b)(6) medical (b)(4) reviewed the complaint and stated: "the death was not related to the device, and was procedure-related".The instructions for use supplied with the device states: "do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance.Vessel or catheter damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels." "potential adverse events that may occur and/or require intervention include, but are not limited to: aortic damage, including perforation, dissection, bleeding, rupture; death; renal complications and subsequent attendant problems (e.G., artery stenosis or occlusion, contrast toxicity, infarct, insufficiency, failure); and vessel damage." "when a satisfactory graft position has been achieved, exchange the contralateral angiographic catheter and wire guide with a selective wire guide/selective catheter positioned just below the level of the proximal body.Cannulate the partially deployed proximal main body.Advance the selective catheter over the selective wire guide into the renal artery.Exchange the selective wire with a rosen wire or equivalent wire guide." "utilizing contralateral access sheath and wire guide, advance a guiding catheter into each fenestration and its respective vessel." based on the information present, there is no evidence that a device non-conformance or deficiency contributed to the complaint.The complaint reported appears to be related to procedural factors during cannulation of the wire.
Event or Problem Description
The device was placed successfully.While cannulating, the wire (boston scientific wire) went out too far into the renal artery and perforated the renal artery.The device user attempted to control the bleeding and believed the patient was hemodynamically stable.The procedure continued and 3 additional grafts were placed 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: 7360275
• Report Number: 9680654-2018-00009
• Device Sequence Number: 1273691
• Product Code: MIH
• UDI-Device Identifier: 10827002325330
• UDI-Public: (01)10827002325330(17)210207(10)AC1011467
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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 Model Number: G32533
• Device Catalogue Number: ZFEN-P-2-30-94-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/15/2018
• 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: Death
• Patient Age: 66 YR