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

Model Number	G32533
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been reported by the manufacturer under mdr#9680654-2019-00039.
Event or Problem Description
Patient underwent a aaa repair on (b)(6) 2019 for a aaa in which the following devices were implanted: zfen-p-2-30-94-r.Zfen-d-12-28-76-c, zsle-30-39-zt (left iliac), zsle-20-74-zt (right iliac), and esbe-26-39-zt.A small endoleak was noted and the physician placed the esbe device which resolved the leak.The patient returned for scheduled follow up on (b)(6) 2019 and an endoleak, possible type ii, and the physicians partner suggested possible type ii endoleak via angiogram.A follow up procedure to address the leak was scheduled for (b)(6) 2019.On friday (b)(6) 2019, the follow up procedure to determine where the endoleak was located could not be determined.As the physician noted this was a brisk endoleak it was decided to re-align the device at the bifurcation.Physician did images with coda balloon to see if overlap leaked but was unsuccessful in determining.A zsle-20-56, lot# 9670741, was deployed in the left iliac but did not stop the leak.The physician then deployed an esbe-30-39-zt- lot# 9888654, a zsle-20-90-zt- lot# 9835111 (right iliac) and a zsle-20-74-zt- lot# 9748250 (left iliac).Did a kissing cota balloon and a final angiogram showed no leak.The patient was discharged to go home the following day, saturday.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL 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: 9157863
• Report Number: 3005580113-2019-00484
• Device Sequence Number: 18944454
• Product Code: MIH
• UDI-Device Identifier: 10827002325330
• UDI-Public: (01)10827002325330(17)220430(10)AC1036635
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2019
• Report Date (Section F): 10/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: G32533
• Device Catalogue Number: ZFEN-P-2-30-94-R
• Device Lot Number: AC1036635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/17/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 10/04/2019