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	G32534
Health Effect - Clinical Codes	Death (1802); Ischemia (1942)
Date of Event	01/07/2018
Type of Reportable Event	Death
Event or Problem Description
The physician felt the device caused or contributed to the patient's death.
Additional Manufacturer Narrative
The device was not returned for evaluation.Procedural images and operative reports were provided and reviewed by william cook (b)(4) medical director: "this patient had a pre-existing endovascular aneurysm repair (evar) but had developed a type 1a endoleak at the top end, and showed increasing diameter of his abdominal aortic aneurysm (aaa) to over 90mm.Various extra grafts were inserted endoluminally.An endologix graft was deployed inside the previous evar, and "medtronix" iliac grafts were 'place' from there into the iliac vessels.A cook zfen had been made with three fenestrations, but when measured against the patient on the operating table, the zfen was going to extend above the coeliac trunk.Therefore, a physician-modified graft was created, pulling the device out of the sheath, creating a new fenestration to correspond to the coeliac trunk, then the device was re-sheathed, and deployed.There was difficulty in stenting the left renal (previous stent had a stenosis) and the right renal (tight stenosis in the native vessel).These were, however, able to be stented eventually.The main problem was the superior mesenteric artery (sma) ¿ it was noted in the operation notes that this was ¿extremely diseased¿ and it required pre-dilation before the sma stent could be deployed.There was a persistent endoleak after a long complex procedure, and this looks to have been the same type 1a endoleak shown on the earlier ct from (b)(6) 2017.This procedure was performed on (b)(6) 2018.Two days later, on (b)(6), the patient complained of abdominal pain, and a ct angio performed showed the endoleak, an apparently patent sma, coeliac, and both renals, but it also showed marked presence of gas bubbles in the bowel wall, mainly in the colon.This was worrying for ischaemia, so a laparotomy was performed, and while the small bowel was ischaemic but not necrotic, the large bowel was extensively necrotic and gangrenous, so was excised.An iliac-to-sma bypass was also done to try and improve flow in the mesenteric circulation.No details are given as to subsequent progress, other than that the patient died.My impression is that the pre-dilation of the sma origin prior to deployment of the sma stent most likely caused showers of emboli from ruptured plaque and calcific debris, and although the main stem of the sma looks patent on the ct scan, the terminal branches would be occluded by micro emboli, causing the ischaemic colon.This was all due to the diseased condition of the patient¿s aaa and arterial system, and not through any fault of the various stent grafts that were used (endologix, medtronix, cook, and atrium).I can¿t see any reason to suggest a failure of our device specifically, either procedural or in the design or manufacture." work order (b)(4) was reviewed and appears complete and correct.Upon reviewing the photos taken of the complaint device during manufacture it appears that the device was manufactured as per the device order form signed by the physician.The device ifu states: "the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft, or stenosis/occlusion of vessels accommodated by fenestrations) should receive enhanced follow-up"."inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia." potential adverse event includes: "bowel complications (e.G., ileus, transient ischemia, infarction, necrosis)", "embolization (micro and macro) with transient or permanent ischemia or infarction" and "death".William cook (b)(4) medical director highlighted the fact that the device was used off label as the cook graft was pulled out of the sheath to create a new fenestration to correspond to the coeliac trunk, device was than re-sheathed, and deployed.There is no evidence that a device non-conformance or deficiency contributed to the complaint.The complaint appears to be related to procedural factors.
Event or Problem Description
The physician felt the device caused or contributed to the patient's death.

• 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: 7891974
• Report Number: 9680654-2018-00028
• Device Sequence Number: 11240126
• Product Code: MIH
• UDI-Device Identifier: 10827002325347
• UDI-Public: (01)10827002325347(17)201120(10)AC1007111
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 11/20/2020
• Device Model Number: G32534
• Device Catalogue Number: ZFEN-P-2-32-94-R
• Device Lot Number: AC1007111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/28/2018
• 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: Death
• Patient Age: 82 YR