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	G32554
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been reported by the manufacturer under mdr# 3002808486-2019-00037.
Event or Problem Description
The patient underwent a procedure on (b)(6) 2018 to repair an abdominal aneurysm.A zfen-p-2-34-137-r (lot ac1025994), zfen-d-12-28-91-c (lot ac1025995), zsle-13-56-zt (lot 8966438), and zsle-16-56-zt (lot 9037918) were placed.A type 4 endoleak was noted and appears to be with the left common iliac.A zsle-13-39-zt (lot 8409848) was placed to reline.The physician decided to wait 30 days for the endoleak to resolve.The endoleak did not resolve on its own.On (b)(6) 2019 the physician went in to see if a cook cuff could be placed as the leak was now believed to be above flow divider at the distal graft.Focal leak could not be identified on cta or selective angiograms, so the fevar stent was 80% relined with bilateral two gore limbs and a gore cuff.Endoleak persisted a month later and still appeared diffuse, so stent was relined a second time up to renal fenestrations and converted to aorto-uni-iliac and fem-fem, which resulted in complete resolution of leak.Patient continues to do well after complete relining with no further endo leaks.

• 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: 9141855
• Report Number: 3005580113-2019-00458
• Device Sequence Number: 447024
• Product Code: MIH
• UDI-Device Identifier: 10827002325545
• UDI-Public: (01)10827002325545(17)211023(10)AC1025995
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2019
• Report Date (Section F): 10/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2021
• Device Model Number: G32554
• Device Catalogue Number: ZFEN-D-12-28-91-C
• Device Lot Number: AC1025995
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2019
• 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: 76 YR
• Date Report Sent to FDA: 10/01/2019