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 Coagulation in Device or Device Ingredient (1096); Obstruction of Flow (2423)

Patient Problems Renal Disease, End Stage (2039); Thrombosis (2100); Thrombus (2101)

Event Type  Injury  

Event Description

Renal stent thrombosis resulting in renal insufficiency.Reintervention was performed for the renal artery stent thrombosis.

Manufacturer Narrative

The device was not returned for evaluation.There is no device information available to review, therefore the review of the device history record could not be performed.The ifu for fenestrated endovascular devices lists renal complications as a potential adverse event, and states: "the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft".A definitive root cause could not be determined from the available information.

Event Description

Renal stent thrombosis resulting in renal insufficiency.Reintervention was performed for the renal artery stent thrombosis.

• 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 QLD 4 113; AS QLD 4113
• MDR Report Key: 11025053
• MDR Text Key: 222014457
• Report Number: 9680654-2020-00045
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

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
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention