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

Catalog Number	ZFEN-P-2-30-124-R
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report relates to report 9680654-2017-00006.This report relates to report 9680654-2017-00006.
Event or Problem Description
In (b)(6) of 2014, proximal and distal fenestrated devices were implanted in the patient without incidence.On follow up ct scan of (b)(6) 2016, it was noted to have component separation of the proximal body and distal body.On (b)(6) 17, a device was used to bridge the two components back together.A second additional device was then placed for additional radial force between the proximal and distal to hopefully keep it from separating again.
Additional Manufacturer Narrative
This report relates to report 9680654-2017-00006.The graft remains in situ, and therefore, was not returned for evaluation.Additional information was requested from the doctor and received."i believe there was separation of the z-fen main body.It looked to me that we had about 1 stent over lap at the time of implantation.He had some tortuosity but not severe so i was surprised that this happened." no imaging was received from the original procedure when these grafts were implanted, and therefore it could not be confirmed that there was "about 1 stent over lap at the time of implantation".Medical imaging was received and reviewed by william a cook (b)(4)."the separation of the proximal and distal components of the graft can be seen very clearly, resulting in a type iii endoleak.Fortunately for this patient, the aneurysm sac had filled with thrombus, which had presumably organised (become hard and fibrous), so the endoleak didn¿t result in full revascularisation of the aaa and no rupture occurred.The endoleak looks to be contained to the immediate vicinity of the graft separation." "the endoleak was picked up on routine follow-up ct scan, and an alpha bridging graft and a palmaz stent was used to bridge the defect/leak and resolve the problem.According to the information, this was successful and the patient had no problems." "the type iii endoleak can be confirmed, and is a result of graft component separation due to deformation of the graft.I can¿t comment on whether or not the graft was inserted in this deformed configuration or if it happened subsequently, as i don¿t have the original images from the graft deployment." the work order record for (b)(4) was reviewed and appeared complete and correct.The ifu supplied with the 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." "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)." "the proximal body graft and distal body graft are available in multiple lengths.The chosen lengths should provide a minimum two-stent overlap should the graft components align completely along the greater curve of the aorta/aneurysm over time planning for a longer overlap length initially (e.G., 3-4 stents) is therefore preferable." "repeat angiogram to verify: ¿ the degree of overlap with proximal body (no less than 2 stents) ¿ the position of the contralateral limb ¿ the position of the ipsilateral iliac limb with respect to the common iliac bifurcation." and "reposition distal bifurcated body as required." based on the information present, a definitive root cause of the complaint could not be identified.It is possible that one or more of the following factors could have contributed to the complaint: - graft sizing; - graft migration; - patient-related factors.As stated in the additional information received, it is possible that planning or procedure-related factors could have also contributed to the complaint, where the grafts were implanted with less than 2 stents of overlap.
Event or Problem Description
In (b)(6) of 2014, proximal and distal fenestrated devices were implanted in the patient without incidence.On follow up ct scan of (b)(6) 2016, it was noted to have component separation of the proximal body and distal body.On (b)(6) 2017, a device was used to bridge the two components back together.A second additional device was then placed for additional radial force between the proximal and distal to hopefully keep it from separating again.

• 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: 6390245
• Report Number: 9680654-2017-00007
• Device Sequence Number: 317886
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)170827(10)AC941960
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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 Catalogue Number: ZFEN-P-2-30-124-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 05/02/2017
• 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-D-12-28-76-C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR