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	G32536
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994); Urinary Retention (2119)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's fenestrated graft procedure happened on the (b)(6) 2017.The patient received the device and 2 additional i-cast stents (not manufactured by cook medical).In the middle of the afternoon on (b)(6) 2017 the patient started complaining of back pain and had no urine production (anuric).The patient was taken to the operating room in the afternoon of (b)(6) for an angiogram.The doctor did angios of the abdominal aorta and selective angios of each renal artery.Both renal arteries were found to be occluded at the distal end of the renal i-cast stents.Thrombectomy & percutaneous transluminal angioplasty was performed to restore blood flow in the renal arteries.
Additional Manufacturer Narrative
The complaint device was not returned for evaluation and remains in-situ.Work order (b)(4) was reviewed and appears to be complete and correct.The device ifu states: ¿in the event that small fenestrations are being utilized, stents may be placed to secure positive alignment.¿ ¿standard techniques for placement of arterial stents should be employed during use of stents." occlusion of native vessel is listed in the adverse events section of the ifu all documentation from the product file has been reviewed and the graft appears to have been correctly manufactured and qc checked.Imaging was requested and answer was received advising that none was available.The doctor in charge of the case was quoted saying: "the doctor feels that the small diameter of the renal arteries in combination with the i-cast stents caused the problem." "renal occlusions started at the distal end of the i-cast stents out in the renal arteries and not within the graft." ¿doctor does not have an opinion as to whether it was the graft or patient anatomy that caused the issue.He explains the graft preformed as expected in previous 20+ cases.¿ based on the information present,there is no evidence that the device was not manufactured according to specification.It was not possible to determine if the renal stents and/or patient anatomy factors contributed to the occlusion.It is possible that patient factors, including intimal hyperplasia, thrombosis, kinking of vessel distal to stent, and/or component factors including, crushing and kinking due to misalignment of graft, could be contributing factors in this case.
Event or Problem Description
The patient's fenestrated graft procedure happened on the (b)(6) 2017.The patient received the device and 2 additional i-cast stents (not manufactured by cook medical).In the middle of the afternoon on (b)(6) 2017 the patient started complaining of back pain and had no urine production (anuric).The patient was taken to the operating room in the afternoon of (b)(6) for an angiogram.The doctor did angios of the abdominal aorta and selective angios of each renal artery.Both renal arteries were found to be occluded at the distal end of the renal i-cast stents.Thrombectomy & percutaneous transluminal angioplasty was performed to restore blood flow in the renal arteries.

• 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: 6769841
• Report Number: 9680654-2017-00020
• Device Sequence Number: 19013987
• Product Code: MIH
• UDI-Device Identifier: 10827002325361
• UDI-Public: (01)10827002325361(17)200505(10)AC995283
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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 Model Number: G32536
• Device Catalogue Number: ZFEN-P-2-26-109-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/06/2017
• Supplement Report FDA Received Date: 09/07/2017
• Patient Sequence Number: 1