MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32578
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report relates to report 9680654-2018-00023.
Event or Problem Description
On (b)(6) 2018, the patient presented with a contained rupture due to a type 3 endoleak of component separation.The proximal and distal pieces were separated.The patient was treated with an abdominal 28 mm cuff to bridge the two components.
Additional Manufacturer Narrative
This report relates to report 9680654-2018-00023.The device was not returned for evaluation and remains in-situ.Images were provided and reviewed by william cook australia medical director: "the original endograft was implanted in early 2015 and a good 3-stent overlap was achieved, with the graft lying nice and straight inside the abdominal aortic aneurysm (aaa).A secondary procedure was performed in 2017 to add iliac leg extensions ¿ no history is available as to why this was done, but presumably due to type 1b endoleak(s) at the lower end(s) of the bifurcated graft.All of the overlap had been lost and the components separated.Also noteworthy is the marked anterior bowing of the graft compared to the straight position of the graft shortly after the initial procedure.When looking at the ct scan from 2017, it can be seen even then that there has been bowing of the graft, with loss of overlap down to 2 stents." work order ac944129 was reviewed and appears complete and correct.The device ifu 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." "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" "potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak, and endoprosthesis (improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion)." based on the information provided, the root cause for the incident cannot be determined.It is possible that the separation was due to: - insufficient fixation (friction) between the proximal and distal components - inadequate retention forces - distal device separation - patient-related factors.The degree of anterior ¿bowing¿ of the graft seems to have increased between the initial procedure and the imaging of the recent hospital admission for ruptured aneurysm.
Event or Problem Description
On (b)(6) 2018, the patient presented with a contained rupture due to a type 3 endoleak of component separation.The proximal and distal pieces were separated.The patient was treated with an abdominal 28 mm cuff to bridge the two components.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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: 7787616
• Report Number: 9680654-2018-00024
• Device Sequence Number: 1287161
• Product Code: MIH
• UDI-Device Identifier: 10827002325781
• UDI-Public: (01)10827002325781(17)171010(10)AC944129
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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 Expiration Date: 10/10/2017
• Device Model Number: G32578
• Device Catalogue Number: ZFEN-D-20-62-76-C
• Device Lot Number: AC944129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: ZFEN-P-2-32-124-R; ZFEN-P-2-32-124-R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR