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

Model Number	G32592
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Occlusion (1984)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with a pre-existing endograft placed at another facility had come in with a total limb occlusion due to thrombus.Physician lysed thrombus and stented iliac limb.Patient is doing well.The limb occlusion caused the patient to be symptomatic.On the contralateral side.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
• Common Device Name: 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: 9826144
• Report Number: 3005580113-2020-00290
• Device Sequence Number: 1367508
• Product Code: MIH
• UDI-Device Identifier: 10827002325927
• UDI-Public: (01)10827002325927(17)220507(10)AC1036826
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2020
• Report Date (Section F): 03/12/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: G32592
• Device Catalogue Number: ZFEN-D-16-62-76-C
• Device Lot Number: AC1036826
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Date Report Sent to FDA: 03/12/2020