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
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	10/22/2021
Type of Reportable Event	Death
Event or Problem Description
No problem with the device was alleged.One day after placement, the patient developed bowel ischemia.The patient required surgery for bowel (colon) resection and colostomy.
Additional Manufacturer Narrative
The graft remains in situ, and therefore was not returned for evaluation.Images were provided and reviewed by the medical director who stated that "the presence of thrombus in the aneurysm (they explicitly state that it was in the aneurysm and not in the endograft) is normal and expected.There is a fair amount of calcified plaque around both the superior mesenteric artery (sma) and coeliac origins in the aortic wall, and on the sagittal view, both vessels look to have less than perfect orifices, with the coeliac in particular looking quite stenotic (narrowed).These findings don¿t necessarily add any information to the likely cause of the bowel ischaemia, although the aortic wall disease may have been a contributing factor".The medical director also stated "i doubt that it was due to a failure or fault with the device, and on the balance of the limited evidence we have the cause of the delayed occlusion could range from dissection of the sma, misalignment of the sma fenestration perhaps with slight ¿settling¿ movement of the endograft (unlikely), or distortion of the proximal end of the sma stent perhaps due to delivery system manipulation during the procedure.However, due to the lack of information provided a definitive root cause could not be established¿.Additional information was received that the graft had been examined prior to use and then successfully implanted following the instructions for use (ifu).There was some difficulty positioning the graft due to access, but it was possible to align the branches, fenestrations and scallops with the native vessels, eventually, with some rotation.The patient¿s anatomy was reported to be tortuous, causing the delivery system to require to be twisted to get it in rotation of the delivery system was performed together as per the ifu instructions.Calcification was present in the vessels containing the grafts.No difficulty was reported accessing fenestrations/scallops/branches, dilators used in the access vessels.The trigger wires were able to be withdrawn and top cap deployed and was able to be removed and docked for withdrawal with no difficulty.No resistance on withdrawal of the device was reported.No part of the delivery system was damaged during the procedure.A vascular closure device was used pre-access.Work order (b)(4) was reviewed for 1 x zfen-p-2-32-94-r.The work order appeared complete, and the quality control inspection was verified to ensure that the device passed inspection.Relevant manufacturing documentation was reviewed in order to identify if there are controls in place that would identify a non-conformance that could have contributed to the event.Upon reviewing the photos taken of the complaint device during manufacture it appears that the device was manufactured as per specifications.The instructions for use (ifu) supplied with the device states: ¿4.2 patient selection, treatment and follow-up ¿ access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease, and/or calcification) ¿ should be compatible with vascular access techniques and delivery systems of the profile of a 14 french to 22 french vascular introducer sheath.Iliac conduits may be used to ensure the safe insertion of the introduction system.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization/trauma.¿ 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.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.5 adverse events ¿ bowel complications (e.G., ileus, transient ischemia, infarction, necrosis) 11.4.5 proximal body placement caution: to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).¿ based on the information and imaging received, a definitive root cause could not be established.It is possible that one or more of the following factors could have contributed to the reported event: twisting of implant within the delivery system.Kinking/ collapse/excessive prolapse of implant/folding of implant material between stents.Collapse of implant due to stent fracture/detachment.Rough surface prone to thrombus formation.Inadequate medication of patient with anticoagulants.Inadequate spacing between stents.Patient related factors.
Event or Problem Description
No problem with the device was alleged.One day after placement, the patient developed bowel ischemia.The patient required surgery for bowel (colon) resection and colostomy.The patient expired a few days after the procedure.

• 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
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: meena harish ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 12749910
• Report Number: 9680654-2021-00020
• Device Sequence Number: 7814870
• Product Code: MIH
• UDI-Device Identifier: 10827002325347
• UDI-Public: (01)10827002325347(17)240908(10)AC1086714
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: G32534
• Device Catalogue Number: ZFEN-P-2-32-94-R
• Device Lot Number: AC1086714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Male