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 G32561

Device Problems Patient-Device Incompatibility (2682); Material Twisted/Bent (2981)

Patient Problems Muscle Weakness (1967); Weakness (2145)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

N/a.

Event Description

The initial procedure went as intended.The patient returned to the hospital complaining of left leg weakness.Duplex doppler was performed and high velocity was noted in the external iliac artery.The patient was brought in for an aortagram and it was confirmed that there was a kink in the ipsilateral leg of the device.An intervention was performed.

Manufacturer Narrative

The device was not returned for evaluation.Additional information was received: how long after the initial procedure did the patient present with leg weakness? roughly 2 weeks after implant the patient presented with leg weakness.Is any imaging, procedural notes, and planning/sizing information available? i have the imaging for planning/sizing but not the intraoperative imaging.What interventional measure were taken to rectify this occurrence? they placed a gore vbx balloon expandable covered stent to fix the kinked ipsilateral leg.In addition to the leg weakness, were any other adverse events reported? no other adverse event reported other than diminished left leg pulses and weakness.Work order: (b)(4) 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." "to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula)." "inaccurate placement and/or incomplete sealing of the zenith fenestrated aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.It is recommended that all vessels accommodated by a small fenestration be stented in order to secure positive alignment of the graft fenestration with the vessel origin." "potential adverse events that may occur and/or require intervention include, but are not limited to: 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." from the information available in this investigation it is difficult to determine a definitive root cause.There is no evidence to indicate that the device was not manufactured to specification or that a device non-conformance or deficiency contributed to this complaint.It is possible that one or more of the following factors may have contributed to the complaint: kinking/ collapse/ excessive prolapse of implant/folding of implant material between stents.Procedural factors.Patient factors.

Event Description

The initial procedure went as intended.The patient returned to the hospital complaining of left leg weakness.Duplex doppler was performed and high velocity was noted in the external iliac artery.The patient was brought in for an aortagram and it was confirmed that there was a kink in the ipsilateral leg of the device.An intervention was performed.

Manufacturer Narrative

The device was not returned for evaluation.Three requests were made to acquire additional information and medical imaging, but a response was not received.Work order ac1026799 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." "to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula)." "inaccurate placement and/or incomplete sealing of the zenith fenestrated aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.It is recommended that all vessels accommodated by a small fenestration be stented in order to secure positive alignment of the graft fenestration with the vessel origin." "potential adverse events that may occur and/or require intervention include, but are not limited to: 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." from the information available in this investigation it is difficult to determine a definitive root cause.There is no evidence to indicate that the device was not manufactured to specification or that a device non-conformance or deficiency contributed to this complaint.It is possible that one or more of the following factors may have contributed to the complaint: kinking/ collapse/ excessive prolapse of implant/folding of implant material between stents, procedural factors, patient factors.

Event Description

The initial procedure went as intended.The patient returned to the hospital complaining of left leg weakness.Duplex doppler was performed and high velocity was noted in the external iliac artery.The patient was brought in for an aortagram and it was confirmed that there was a kink in the ipsilateral leg of the device.An intervention was performed.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
• Type of Device: 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: 8234034
• MDR Text Key: 132647810
• Report Number: 9680654-2019-00001
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325613
• UDI-Public: (01)10827002325613(17)211107(10)AC1026799
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: G32561
• Device Catalogue Number: ZFEN-D-12-45-76-C
• Device Lot Number: AC1026799
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/21/2018; 12/21/2018
• Supplement Dates FDA Received: 01/21/2019; 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention