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	G32547
Health Effect - Clinical Codes	Occlusion (1984); No Code Available (3191)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The doctor realized that as he was advancing the device it rotated due to the anatomy and was landed upside down.The graft covered the superior mesenteric artery (sma) and right renal.The event led to open removal of graft and open repair.
Additional Manufacturer Narrative
The device was not returned for evaluation.The work order (b)(4) was reviewed and appears complete and correct.The doctor in charge of the case confirmed that the accident was a result of a human error.
Event or Problem Description
The doctor realized that as he was advancing the device it rotated due to the anatomy and was landed upside down.The graft covered the superior mesenteric artery (sma) and right renal.The event led to open removal of graft and open repair.

• 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: 8681368
• Report Number: 9680654-2019-00018
• Device Sequence Number: 11339919
• Product Code: MIH
• UDI-Device Identifier: 10827002325477
• UDI-Public: (01)10827002325477(17)220401(10)AC1034892
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 04/01/2022
• Device Model Number: G32547
• Device Catalogue Number: ZFEN-P-2-34-122-R
• Device Lot Number: AC1034892
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/09/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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