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 G32549

Device Problems Device Slipped (1584); Separation Failure (2547); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The graft system was implanted approximately three years ago.Recently, the bifurcated graft separated from the tube graft and came out of tube graft.The physician had to reline the endograft and was able to fix the graft system.

Manufacturer Narrative

No part of the device was returned for evaluation.The medical director reviewed the supplied imagining and stated: 'this case is a separation between the two main graft components.It is device-related, due to the same diameter fit at the overlap between the two components, combined with the presence of a large aneurysm.The endograft gradually works its way across the aneurysm and comes to lie against the wall of the aneurysm.This horizontal movement over time results in the distal component pulling out of the proximal one, which is held in place by its bridging stents.In summary ¿ this is a case of graft separation almost certainly caused by the slip fit between the two main graft components at the overlap, despite a good 3-stent overlap at the time of implant.' additional information was received as follows: additional products used during the implant procedure: cook coda balloon.The instructions for use (ifu) were followed during the implant procedure, no issue during implant.Ballooning was performed on the top 2 seal stents of proximal piece, overlap zone of bifurcated graft inside of proximal piece, and distal seal zone in each common iliac.The patient was on intraoperative heparin.The type iii endoleak was between bifurcated and proximal grafts.No separation was noted between the distal graft and leg graft.Covered stents were placed in the renal arteries through the small fenestrations.1/3 overlap of the covered stent was left inside the aorta.The intra-aortic segment of the covered stent was flared with an oversized angioplasty balloon.The implanted graft/stent migrated over time.There was clear separation between graft components.Regular follow up scans were done as per ifu.The migration was found on scans, which made reintervention necessary.There was no evidence of twisting of the grafts within graft components.The relevant work order for lot ac1028670 appears complete and correct.The device was manufactured to specification.A review of specification found that there a number of processes and checks in place which would likely identify a device deficiency prior to shipment.The instruction for use (ifu) supplied with this device provides following information: warnings and precautions 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.Specific follow-up guidelines are described in section 12.After endovascular graft placement, patients should be regularly monitored for peri graft 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, peri graft 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.Patient selection, treatment and follow-up' states "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" 'adverse events' states "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; peri graft flow; barb separation and corrosion).'distal bifurcated body placement', step 11.4.8.6 states, "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 provided, and review of the provided imaging, a definitive root cause could not be determined.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 anatomy factors.

Event Description

The graft system was implanted approximately three years ago.Recently, the bifurcated graft separated from the tube graft and came out of tube graft.The physician had to reline the endograft and was able to fix the graft system.

• 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 (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: meena harish ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 14750510
• MDR Text Key: 294878316
• Report Number: 9680654-2022-00009
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325491
• UDI-Public: (01)10827002325491(17)211207(10)AC1028670
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2021
• Device Model Number: G32549
• Device Catalogue Number: ZFEN-P-2-34-137-R
• Device Lot Number: AC1028670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male