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	G32539
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
During cat scan the physician noted that the proximal / distal devices had separated causing a type iii endoleak.Secondary intervention was performed on (b)(6) 2019.The physician placed 2 additional grafts ( zdeg-p-28-82-pf-us and a esbe-28-58-zt) inside the proximal and distal zfen grafts to bridge the gap and seal the devices.Final angiogram looked good and showed no evidence of endoleak.
Event or Problem Description
During cat scan the physician noted that the proximal / distal devices had separated causing a type iii endoleak.Secondary intervention was performed on (b)(6) 2019.The physician placed 2 additional grafts ( zdeg-p-28-82-pf-us and a esbe-28-58-zt) inside the proximal and distal zfen grafts to bridge the gap and seal the devices.Final angiogram looked good and showed no evidence of endoleak.
Additional Manufacturer Narrative
The device remains in situ and therefore has not been returned for evaluation.Three unsuccessful requests to obtain medical imaging were made.The work order: (b)(4) was reviewed and appears complete and correct.The device ifu states: "potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak"."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." based on the information provided, the root cause is unknown.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 between the initial procedure and the event reported.

• 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: 9551139
• Report Number: 9680654-2020-00002
• Device Sequence Number: 19366320
• Product Code: MIH
• UDI-Device Identifier: 10827002325392
• UDI-Public: (01)10827002325392(17)191118(10)AC985418
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 11/18/2019
• Device Model Number: G32539
• Device Catalogue Number: ZFEN-P-2-32-109-R
• Device Lot Number: AC985418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/02/2020
• 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: Required Intervention
• Patient Age: 74 YR