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

Catalog Number	ZFEN-P-2-34-122-R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1188 days post-procedure, an intervention was performed to treat aneurysm growth due to what was thought to be a type ii endoleak.During the procedure the endoleak was found to be at the junction between the left renal stent and left renal fenestration.Angioplasty was performed and an icast stent was placed in the left renal artery.The intervention was successful.The site revised its assessment from a type ii endoleak to a proximal type i endoleak on (b)(6) 2016.
Additional Manufacturer Narrative
The device was not evaluated because it was not returned to manufacturer.The work order record for batch ac885364 was reviewed and appeared complete and correct, and review of the complaint device's photos taken during manufacture concluded that the endovascular graft was manufactured as per specification.The ifu states that life-long, regular follow-up is required for patients to assess their health and the performance of their endovascular graft; that at minimum, annual imaging is required; and lists endoleak as a potential adverse event.The information and imaging present were reviewed, and it was confirmed that there was an endoleak at the junction of the left renal artery and the left renal fenestration.It was concluded that the endoleak was most likely caused by technical difficulty in flaring / sizing / positioning the first renal stent.An adequate seal was not achieved, resulting in the endoleak.There does not appear to be any device non-conformance that contributed to the complaint.(b)(4).Appropriate personnel will continue to monitor for similar events.
Event or Problem Description
On 1188 days post-procedure, an intervention was performed to treat aneurysm growth due to what was thought to be a type ii endoleak.During the procedure the endoleak was found to be at the junction between the left renal stent and left renal fenestration.Angioplasty was performed and an icast stent was placed in the left renal artery.The intervention was successful.The site revised its assessment from a type ii endoleak to a proximal type i endoleak on (b)(6) 2016.

• 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: 5821247
• Report Number: 9680654-2016-00005
• Device Sequence Number: 18929252
• Product Code: MIH
• UDI-Device Identifier: 10827002325477
• UDI-Public: (01)10827002325477(17)140831(10)AC885364
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2016

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 Catalogue Number: ZFEN-P-2-34-122-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2016
• Supplement Report FDA Received Date: 08/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 108