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-2-24-94-R

Device Problems Fluid/Blood Leak (1250); Torn Material (3024)

Patient Problems Pain (1994); Blood Loss (2597)

Event Date 12/28/2016

Event Type  No Answer Provided  

Event Description

Patient presented to the facility due to symptoms of back pain.A ct scan was performed and an endoleak (believed to be type iii) was found in the graft where the devices overlap.An angiogram was performed to determine there was a leak/tear between the overlap.A cut down was then performed on right groin and an additional graft was placed.

Manufacturer Narrative

The complaint device was implanted in 2013 and the graft remains in situ, therefore the device was not returned for evaluation.Upon reviewing the photos taken of the complaint device during manufacture, it appeared that the endovascular graft was manufactured as per specifications.The work order record for ac922978 was reviewed and appeared complete and correct.The instructions for use supplied with the complaint device state: "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." "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)." "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." the imaging received was reviewed by the medical director (md): "i agree that there was a type iii endoleak at the junction of the proximal and distal grafts, shown on the ct and the angio still frames.This appears to be where there is a marked anterior curvature of the grafts, causing the distal component of the graft to insert into the proximal portion at an angle.This is best seen on the lateral view ct.The leak is confirmed on the subsequent angiogram still frames.The subsequent secondary intervention, to place an additional stent graft across the leaking junction appears to have been successful, with cessation of the type iii endoleak.I note that there is no report of patient death, so a satisfactory secondary intervention was performed.My opinion is that the endoleak was not caused by any inherent failure of the implanted devices, but rather by the marked anterior curvature of the devices.This is usually the result of patient height decrease secondary to osteoporosis of the vertebral column and its associated crush/wedge fractures.The state of the patient¿s spine can¿t be seen or assessed on the original still frame angiograms from 2013, as they were all taken as ap views and subtraction was applied.However, on the lateral view ct scans from (b)(6) 2016, the vertebral column looks markedly degenerated, and this may have caused some height loss in the patient, with subsequent ¿buckling¿ forward of the previously-placed endograft." 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.It is possible that patient-related factors contributed to the complaint as per the md's evaluation, which stated that the type iii endoleak was caused by the "marked anterior curvature of the devices.This is usually the result of patient height decrease secondary to osteoporosis of the vertebral column and its associated crush/wedge fractures." there is no evidence that a device nonconformance or deficiency contributed to the complaint.

Event Description

Patient presented to the facility due to symptoms of back pain.A ct scan was performed and an endoleak (believed to be type iii) was found in the graft where the devices overlap.An angiogram was performed to determine there was a leak/tear between the overlap.A cut down was then performed on right groin and an additional graft was placed.

• 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
• Manufacturer Contact: nicolas bidaud ; 95 brandl street; eight mile plains; brisbane, qld 4113 ; AU 4113 ; 738411188
• MDR Report Key: 6255127
• MDR Text Key: 64922105
• Report Number: 9680654-2017-00001
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZFEN-P-2-24-94-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ZENITH DISTAL BIFURCATED BODY ZFEN-D-12-28-76-C
• Patient Age: 89 YR