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	G32542
Health Effect - Clinical Code	Death (1802)
Date of Event	05/27/2017
Type of Reportable Event	Death
Event or Problem Description
The patient had a fenestrated endograft placed on (b)(6) 2017.The patient presented at the hospital on (b)(6) 2017 with ruptured pseudoaneurysm off of the left renal artery (8 days post op).The physician called the clinical specialist to request information regarding the initial case, which the clinical specialist stated was a standard case (completed successfully).The physician informed the clinical specialist that the left renal artery was embolized in an attempt to stop the bleeding form the ruptured pseudoaneurysm.The physician requested additional information regarding any possible intervention if it would be needed.The physician stated during this call that the patient seemed more stable than when they presented with the ruptured pseudoaneurysm.The clinical specialist checked on the patient with the facility on (b)(6) 2017 and was informed the patient had expired.
Additional Manufacturer Narrative
The complaint device was not returned for evaluation.Additional information and medical imaging was requested and to date, no response has been received.The work order record was reviewed and appeared complete and correct.There were no non-conformances raised or temporary deviations effective at the time of manufacture.Photographs taken of the graft during manufacturing were reviewed and the graft appeared to have been manufactured as per the fenestration layout.The instructions for use supplied with the complaint device states: "the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft, or stenosis/occlusion of vessels accommodated by fenestrations) should receive enhanced follow-up." "after endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth, patency of vessels accommodated by a fenestration/scallop, or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is recommended, including: 1) abdominal radiographs to examine device integrity (separation between components, stent fracture or barb separation) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information." "potential adverse events that may occur and/or require intervention include, but are not limited to: aortic damage, including perforation, dissection, bleeding, rupture and death; arterial or venous thrombosis and/or pseudoaneurysm; death; vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection." based on the information present a definitive root cause of the complaint could not be determined.
Event or Problem Description
The patient had a fenestrated endograft placed on (b)(6) 2017.The patient presented at the hospital on (b)(6) 2017 with ruptured pseudoaneurysm off of the left renal artery (8 days post op).The physician called the clinical specialist to request information regarding the initial case, which the clinical specialist stated was a standard case (completed successfully).The physician informed the clinical specialist that the left renal artery was embolized in an attempt to stop the bleeding form the ruptured pseudoaneurysm.The physician requested additional information regarding any possible intervention if it would be needed.The physician stated during this call that the patient seemed more stable than when they presented with the ruptured pseudoaneurysm.The clinical specialist checked on the patient with the facility on (b)(6) 2017 and was informed the patient had expired.

• 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: 6652651
• Report Number: 9680654-2017-00014
• Device Sequence Number: 1150160
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)200419(10)AC993745
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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: G32542
• Device Catalogue Number: ZFEN-P-2-28-124-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 08/03/2017
• 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