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

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Renal stent thrombosis resulting in renal insufficiency.Reintervention was performed for the renal artery stent thrombosis.Renal stent patency was successfully restored in one patient with thrombolysis.

• 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: 11065135
• MDR Text Key: 223393842
• Report Number: 3005580113-2020-00471
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020,12/23/2020

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?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• 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