MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED GRAFT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

Device Problems Component or Accessory Incompatibility (2897); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Type  Injury  

Event Description

User mentioned that the only zfen renal occlusions he has seen have occurred when 5mm stent was used in the renal (3 of 4 patients receiving 5mm stent have occluded).This (b)(4) will investigate 2 of the 3 events of zfen renal occlusions he has seen have occurred when 5mm stent was used.[the other occurrence is covered by (b)(4).See (b)(4) for: left renal stent occluded, infarcted kidney, patient on dialysis.Mentioned that the stent used for renal artery was 5mm stent (non-cook).

Manufacturer Narrative

No part of the device was returned for evaluation.Images were not provided for review despite multiple requests.The medical director reviewed the information available and stated that the occurrences are almost certainly due to very small diameter l.Renal bridging stents (5mm) (most renals take a 6-8mm bridging stents) and possibly some pre-existing renal artery disease, though that cannot be confirmed due to lack of information.The occlusions (thrombosis) of l.Renal bridging stents, but no fault or failure of the main body of the devices as far as he can tell from the very limited information available.Review of the device history records could not be conducted as no lot information was supplied, therefore manufacturing records were not able to be reviewed.Although the lot numbers are unknown, the instructions for use (ifu) currently supplied with zfen-us devices for general information was reviewed and found to contain appropriate warnings, precautions, and instructions to the user, including: 4.2 patient selection, treatment and follow-up: ¿ access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease, and/or calcification) should be compatible with vascular access techniques and delivery systems of the profile of a 14 french to 22 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization/trauma.4.3 implant procedure: ¿ 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.5.Adverse events: potential adverse events that may occur and/or require intervention include, but are not limited to: ¿ arterial or venous thrombosis and/or pseudoaneurysm.¿ occlusion of device or native vessel.¿ renal complications and subsequent attendant problems.(e.G., artery stenosis or occlusion, contrast toxicity, infarct, insufficiency, failure.Review of the instructions for use (ifu) supplied with the device for general information found that it contained appropriate warnings, precautions, and instructions to the user, including: based on the available information, a definitive root cause could not be determined from the investigation.Possible root cause(s) are: - fenestrations diameter on graft larger than diameter of visceral stents.- patient's factor (i.E.A very small renal artery, needing a tiny 5mm bridging stent).

Event Description

User mentioned that the only zfen renal occlusions he has seen have occurred when 5mm stent was used in the renal (3 of 4 patients receiving 5mm stent have occluded).This (b)(4) will investigate 2 of the 3 events of zfen renal occlusions he has seen have occurred when 5mm stent was used.[the other occurrence is covered by (b)(4)].See (b)(4) for: left renal stent occluded, infarcted kidney, patient on dialysis.Mentioned that the stent used for renal artery was 5mm stent (non-cook).

• Brand Name: ZENITH FENESTRATED GRAFT
• 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 ; AS
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 17168473
• MDR Text Key: 317638525
• Report Number: 9680654-2023-00054
• 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: 07/17/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 07/16/2023
• 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): Other