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

Model Number	G32561
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was discovered unconscious at home by a family member and was brought to the hospital where an imaging procedure was performed.Imaging showed that the aneurysm sac appeared to be enlarged and component separation.The patient has refused further treatment.
Event or Problem Description
The patient was discovered unconscious at home by a family member and was brought to the hospital where an imaging procedure was performed.Imaging showed that the aneurysm sac appeared to be enlarged and component separation.The patient has refused further treatment.
Additional Manufacturer Narrative
No product was available for evaluation.Review of the imaging taken from a ct scan in 2019 showed the graft in good position, with a full two-stent overlap between the zfen-p and the zfen-d.Review of the ct scan taken after the patient presented to hospital in (b)(6) 2021 showed graft separation, whereby the zfen-d had pulled out of the zfen-p, following the increased ¿bowing¿ of the graft forward as it moved through the aneurysm and came to lie up against the anterior wall.The zfen-p was noted to still be in good position, held in place by the fixation stent proximally and the two renal bridging stents in the renal fenestrations.The medical director who reviewed the imaging, determined that the increased curvature of the device had caused the zfen-d to pull out of the zfen-p, leading to separation and a full type 3 endoleak, causing re-pressurization of the aneurysm.The relevant work orders were reviewed and appeared complete and correct.A review of review of ifu ¿zenith® fenestrated aaa endovascular graft ifu-fu/3¿ supplied with the device was found to provide sufficient information for patient selection, the deployment of fenestrated grafts, and warning and precautions including the need for patients to 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.Based on the information provided, and review of the supplied imaging, a definitive root cause was unable to be determined.It is possible that the separation was due to: - inadequate diameter tolerance to ensure interference at overlap.- inadequate separation force.- inadequate length of overlap.- patient-related factors.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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: tia gibb ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 12477885
• Report Number: 9680654-2021-00016
• Device Sequence Number: 14408444
• Product Code: MIH
• UDI-Device Identifier: 10827002325613
• UDI-Public: (01)10827002325613(17)220306(10)AC1033237
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 03/06/2022
• Device Model Number: G32561
• Device Catalogue Number: ZFEN-D-12-45-76-C
• Device Lot Number: AC1033237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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: Life Threatening
• Patient Sex: Female