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	G32543
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A supposed type iii endoleak was found on a follow up cta.The cta and subsequent angiogram shows highlighting of contrast next to the contralateral gate just distal to the bifurcation of the distal body.Because of the endoleak the aneurysmal sac has grown.
Additional Manufacturer Narrative
The device was not returned for evaluation.3 unsuccessful requests to obtain additional medical imaging were made.Additional information was received: "there has been attempt at repair of a suspected type ii endoleak prior to this with coil embolization.Because of the type ii/iii endoleak the aneurysmal sac has grown.The distal component was relined." work order (b)(4) was reviewed and appears complete and correct.The ifu supplied with the complaint device for general information only lists endoleak as potential adverse events and states: the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft.Based on the available information, the root cause of the endoleak could not be determined.
Event or Problem Description
A supposed type iii endoleak was found on a follow up cta.The cta and subsequent angiogram shows highlighting of contrast next to the contralateral gate just distal to the bifurcation of the distal body.Because of the endoleak the aneurysmal sac has grown.

• 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: 11963602
• Report Number: 9680654-2021-00011
• Device Sequence Number: 4268729
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)240203(10)AC1073529
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: No Information
• Device Expiration Date: 02/03/2024
• Device Model Number: G32543
• Device Catalogue Number: ZFEN-P-2-30-124-R
• Device Lot Number: AC1073529
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: Life Threatening
• Patient Age: 65 YR