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-2-30-94-R

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

This report is related to report 9680654-2018-00022.

Event Description

The patient came in symptomatic (with possible rupture) and from what the physician could tell on ct scan, it looked like the two components had separated.The physician ended up taking patient to operating room and bridged the two components with a 28x70 cm cuff.The device was originally implanted in 2014 and cts was done in 2015.

Event Description

The patient came in symptomatic (with possible rupture) and from what the physician could tell on ct scan, it looked like the two components had separated.The physician ended up taking patient to operating room and bridged the two components with a 28x70cm cuff.The device was originally implanted in 2014 and cts was done in 2015.

Manufacturer Narrative

This report is related to report 9680654-2018-00022.The device was not returned for evaluation and remains in-situ.A lot number was not provided for the device associated with this complaint, therefore a review of the device history record could not be performed.Imaging associated with this complaint was received and reviewed by william cook australia medical director: "it would seem to be a case of graft separation causing the ruptured aneurysm.On the early ct scan, with the endograft in place, there is at least a 3-stent overlap clearly seen, and the graft is sitting towards the centre of the aneurysm.The outline of the aneurysm is easy to see due to wall calcification.On the recent ct, the graft has bowed right forward to be lying up against the anterior wall of the aneurysm, and has pulled apart, having lost all of its overlap.This can be very clearly seen on both the ct but also on the operative angiogram when the gap was bridged using a cuff graft." 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." "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)." based on the information provided and the image review, a definitive cause could not be established.There is no evidence to indicate that the device was not manufactured to specification.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 seems to have.Increased between the initial procedure and the imaging of the recent hospital admission for ruptured aneurysm.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL 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: 7576388
• MDR Text Key: 110330877
• Report Number: 9680654-2018-00021
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Report Date: 08/09/2018

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 Catalogue Number: ZFEN-P-2-30-94-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZFEN-D-12-62-76-C; ZFEN-D-12-62-76-C
• Patient Outcome(s): Required Intervention