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	G32533
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Ruptured Aneurysm (4436); Renal Impairment (4499)
Date of Event	02/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
3 years post implant, the patient came into the er with an abdominal aortic rupture.Patient underwent open surgery with graft explant and aortic repair.Three days later a wash out was also required.
Event or Problem Description
3 years post implant, the patient came into the er with an abdominal aortic rupture.Patient underwent open surgery with graft explant and aortic repair.Three days later a wash out was also required.
Additional Manufacturer Narrative
The device was not returned for evaluation.The imaging provided was reviewed by the medical director.He stated that the case involves a zfen-p which had a very low left renal fenestration to perfuse an anatomically anomalous left renal artery.Due to that very low left renal, an endologix afx bifurcated component was used instead of a zfen-d.The patient presented with a ruptured aneurysm 27 months post implant.During open surgery, all the endovascular components were removed.The endoleak can be seen arising from the region of the overlap between the zfen-p and the endologix distal component.The reviewer was unable to tell with certainty where the leak was arising from, but given that there was no sign of graft component separation, and that the aneurysm sac was decreasing in diameter on previous follow-up imaging, it is unlikely to have been arising from between the components at the overlap; that would have been much more likely to show up either at the index procedure itself, or very soon after; if there had been a diameter mismatch or inadequate balloon expansion.The fact that all seemed to be going well for 27 months or so would argue strongly that it was not a component separation problem.It is more likely that the leak was arising from a tear in the fabric of the distal component at its bifurcation, which would cause the aneurysm sac to re-pressurize and rupture.There is no indication of any fault or failure of the zfen-p device.Additional information was received that stated: the patient came into the emergency with an abdominal aortic rupture and underwent an open surgery with graft explant and aortic repair.He also required a wash out three days after the open repair.The patient presented with poor kidney function and was very sick while recovering from his open repair.The device was implanted in (b)(6) 2019 and the rupture occurred in (b)(6) 2022.During implant, the device functioned as expected while following the instructions for use (ifu).The graft was able to be deployed in the target zone.The cook fenestrated graft was combined with an endologix afx graft, and it appears that the endoleak is at the afx graft bifurcation.The patient had a short l1 distance (distance from lowest renal to aortic bifurcation) so to fix him endovascularly he needed a shorter bifurcated component than cook offers so an afx bifurcated graft was chosen.There was no graft obstruction or high blood pressure within the graft reported.The manufacturer and implanting physician were not aware of this occurrence until a few days after the event.The work order for lot ac1045073 was reviewed and appears complete and correct.The associated inspection records confirms that the device was manufactured to specification.The review of specifications found that there are number of processes and checks in place to ensure that any device deficiency would be identified prior to shipment.The instructions for use (ifu) supplied with the device was reviewed and states the following: 4 warnings and precautions 4.1 general use information ¿ 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.¿ after endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth, patency of vessels accommodated by a fenestration/scallop, or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is recommended, including: 1) abdominal radiographs to examine device integrity (separation between components, stent fracture or barb separation) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease.¿ intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture.5 adverse events ¿ aneurysm rupture and death.¿ endoleak.Based on the available information, imaging review and the completed investigation, a definitive root cause for the event was not able to be determined.However, it is most likely that there was a tear at the bifurcation of the endologix afx graft, which caused the aneurysm sac to re-pressurize and rupture.

• 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: thejus baby ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 13657403
• Report Number: 9680654-2022-00003
• Device Sequence Number: 12014208
• Product Code: MIH
• UDI-Device Identifier: 10827002325330
• UDI-Public: (01)10827002325330(17)220916(10)AC1045073
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 09/16/2022
• Device Model Number: G32533
• Device Catalogue Number: ZFEN-P-2-30-94-R
• Device Lot Number: AC1045073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• 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
• Patient Age: 76 YR
• Patient Sex: Male