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

Catalog Number ZFEN-D-12-28-76-C

Device Problems Therapeutic or Diagnostic Output Failure (3023); Migration (4003)

Patient Problems Extravasation (1842); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/30/2022

Event Type  Injury  

Event Description

The patient presented with symptoms of a leak as the proximal graft and distal graft had separated.

Manufacturer Narrative

No part of the device was returned for evaluation.A pre-operative image from the repair was available.The medical director reviewed the information supplied in the complaint as well as a single image that was provided and confirmed the separation between the zfen-p and zfen-d causing a leak.Based on the information provided this is a typical separation, whereby the zfen-d has pulled out of the zfen-p, following the increased "bowing" of the graft forward as it moved through the aneurysm.The zfen-p is still in a good position, held in place by the fixation stent proximally, and the two renal bridging stents in the renal fenestrations.The problem is that the increased curvature of the device has caused the zfen-d to pull out of the zfen-p, leading to separation and a full type 3 endoleak, causing re-pressurization of the aneurysm.A review of device record history could not be completed as the lot number is unknown.The instruction for use (ifu) supplied with this device states: 'general use 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." also states "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." a capa was raised to address concerns of separation for the zfen-us devices.The capa determined "the conclusion of the investigation was that there is no fault/non-conformance of the us fen device, its labelling, its ifu, its manufacturing, nor its clinical use.The zfen us configuration meets the acceptance criteria for this product and the acceptance criteria are deemed acceptable." based on the information provided, a definitive root cause could not be determined, however, it is most likely distal device separation, inadequate diameter tolerance to ensure interference at overlap.

Event Description

The patient presented with symptoms of a leak as the proximal graft and distal graft had separated.

• 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
• 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: 15222946
• MDR Text Key: 297860431
• Report Number: 9680654-2022-00014
• 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: 10/11/2022

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-D-12-28-76-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/14/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 70 MO
• Patient Sex: Female