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 Code	Aneurysm (1708)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent an abdominal aortic aneurysm repair on (b)(6) 2019 for an abdominal aortic aneurysm in which the following devices were implanted: zfen-p-2-30-94-r, zfen-d-12-28-76-c, zsle-30-39-zt (left iliac), zsle-20-74-zt (right iliac), and esbe-26-39-zt.A small endoleak was noted and the physician placed the esbe device which resolved the leak.The patient returned for scheduled follow up on (b)(6) 2019 and an endoleak, possible type ii, and the physicians partner suggested possible type ii endoleak via angiogram.A follow up procedure to address the leak was scheduled for (b)(6) 2019.On friday, (b)(6) 2019, the follow up procedure to determine where the endoleak was located could not be determined.As the physician noted this was a brisk endoleak it was decided to re-align the device at the bifurcation.Physician did images with coda balloon to see if overlap leaked but was unsuccessful in determining.A zsle-20-56, lot# 9670741, was deployed in the left iliac but did not stop the leak.The physician then deployed an esbe-30-39-zt- lot# 9888654, a zsle-20-90-zt- lot# 9835111 (right iliac) and a zsle-20-74-zt- lot# 9748250 (left iliac).Did a kissing cota balloon and a final angiogram showed no leak.The patient was discharged to go home the following day, saturday.
Additional Manufacturer Narrative
The device was not returned for evaluation.Imaging associated with this complaint was received and reviewed by the william cook australia medical director."it appears to be more like a type 3 endoleak.It appears to emanate from the junctional area between the zfen-p and the zfen-d.There seems to be sufficient overlap that it isn¿t a case of imminent graft separation, but it may be due to insufficient balloon dilatation of the zfen-d within the zfen-p.I can¿t see any obvious fault or deficiency in the design or structure of the graft components, and there appears to be plenty of overlap at the junctional area." 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 endoleak was due to: patient-related factors or procedure related factors.
Event or Problem Description
Patient underwent an abdominal aortic aneurysm repair on (b)(6) 2019 for an abdominal aortic aneurysm in which the following devices were implanted: zfen-p-2-30-94-r, zfen-d-12-28-76-c, zsle-30-39-zt (left iliac), zsle-20-74-zt (right iliac), and esbe-26-39-zt.A small endoleak was noted and the physician placed the esbe device which resolved the leak.The patient returned for scheduled follow up on (b)(6) 2019 and an endoleak, possible type ii, and the physicians partner suggested possible type ii endoleak via angiogram.A follow up procedure to address the leak was scheduled for (b)(6) 2019.On friday, (b)(6) 2019, the follow up procedure to determine where the endoleak was located could not be determined.As the physician noted this was a brisk endoleak it was decided to re-align the device at the bifurcation.Physician did images with coda balloon to see if overlap leaked but was unsuccessful in determining.A zsle-20-56, lot# 9670741, was deployed in the left iliac but did not stop the leak.The physician then deployed an esbe-30-39-zt- lot# 9888654, a zsle-20-90-zt- lot# 9835111 (right iliac) and a zsle-20-74-zt- lot# 9748250 (left iliac).Did a kissing cota balloon and a final angiogram showed no leak.The patient was discharged to go home the following day, (b)(6).

• 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: 9132545
• Report Number: 9680654-2019-00039
• Device Sequence Number: 449422
• Product Code: MIH
• UDI-Device Identifier: 10827002325330
• UDI-Public: (01)10827002325330(17)220430(10)AC1036635
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 04/30/2022
• Device Model Number: G32533
• Device Catalogue Number: ZFEN-P-2-30-94-R
• Device Lot Number: AC1036635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 09/29/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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: 85 YR