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	G32549
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
The proximal graft separated from the distal graft.They are scheduled for a esbe or tx2 dissection stent to bridge the gap.Intervention procedure is scheduled to take place 'next week' (date of this information was thursday (b)(6) 2020).
Additional Manufacturer Narrative
The device was not returned for evaluation.Upon reviewing imaging available for this complaint william cook australia medical director stated: "the endograft was placed into a large aneurysm, and the imaging we have, which was taken early this year, 2020, so it would be almost 3 years since implant, it can be seen that the endograft has bowed forward to the point where it is virtually in contact with the anterior wall of the abdominal aortic aneurysm sac.The anterior wall of the sac has some significant calcification in it.The distal endograft component has pulled out of the proximal component, resulting in separation with a gap.The sac is also fill with thrombus, and at the point where the two graft components have separated, a small ¿bulging¿ of the contrast material can be seen extruding from the gap between the components, but it looks to be restricted by the thrombus filling the sac.There does not appear to be a large type 3 endoleak at this stage, and i note that the patient was booked to have a re-lining of the device across the separation gap to fix the problem".The work order ac995888 was reviewed and appears complete and correct.The graft appears to be manufactured as per the approved by physician order.The device ifu states that the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established, and 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.Potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak, component migration.The mandatory requirement to always review the complaint history, during a complaint investigation, will ensure that trends are constantly monitored.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.
Event or Problem Description
The proximal graft separated from the distal graft.They are scheduled for a esbe or tx2 dissection stent to bridge the gap.Intervention procedure is scheduled to take place 'next week' (date of this information was thursday (b)(6) 2020.

• 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: 9975869
• Report Number: 9680654-2020-00015
• Device Sequence Number: 3426686
• Product Code: MIH
• UDI-Device Identifier: 10827002325491
• UDI-Public: (01)10827002325491(17)200516(10)AC995888
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/10/2020

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: 05/16/2020
• Device Model Number: G32549
• Device Catalogue Number: ZFEN-P-2-34-137-R
• Device Lot Number: AC995888
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/19/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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: 65 YR