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	G32500
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Final angio showed an endoleak distal to proximal & distal body overlap.Drs.Used a coda balloon to help seal proximal and distal body over lap (about 3.5 stent overlap) & then did another angio.The leak was still there.Drs.Inflated 32 coda balloon in overlap of the proximal & distal body and placed a pigtail marker just distal to the overlap (up the contra side - left iliac) and did an angio to see if there was still a leak.The endoleak was not coming from the proximal & distal body overlap, it looks like it is coming from a hole or tear in the distal pants, just proximal to the contra limb overlap.Drs.Placed an esbe to help seal endoleak.It looks like a small leak is still there.Drs.Plan to rescan patient in the next 30 days or so to see if the leak has sealed off.
Event or Problem Description
Final angio showed an endoleak distal to proximal & distal body overlap.Drs.Used a coda balloon to help seal proximal and distal body over lap (about 3.5 stent overlap) & then did another angio.The leak was still there.Drs.Inflated 32 coda balloon in overlap of the proximal & distal body and placed a pigtail marker just distal to the overlap (up the contra side - left iliac) and did an angio to see if there was still a leak.The endoleak was not coming from the proximal & distal body overlap, it looks like it is coming from a hole or tear in the distal pants, just proximal to the contra limb overlap.Drs.Placed an esbe to help seal endoleak.It looks like a small leak is still there.Drs.Plan to rescan patient in the next 30 days or so to see if the leak has sealed off.
Additional Manufacturer Narrative
The device was not returned for evaluation.The medical director reviewed the supplied imagining and provided the following comments."i can confirm that the endoleak is from the distal bifurcated component of the device." additional information was received.The patient was on heparin at the time of the event.Work order ac1060926 was reviewed and appears complete and correct.The ifu supplied with the complaint device for general information lists endoleak as potential adverse events and states: ¿the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft¿.Based on the information provided a definitive root cause cannot be attributed, it is possible one of the following could have contributed to the reported issue: wear/abrasion/biodegradation at interface site between components; inadequate material selection; procedural 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
• MDR Report Key: 10324446
• Report Number: 9680654-2020-00025
• Device Sequence Number: 19094069
• Product Code: MIH
• UDI-Device Identifier: 10827002325002
• UDI-Public: (01)10827002325002(17)230616(10)AC1060926
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 06/16/2023
• Device Model Number: G32500
• Device Catalogue Number: ZFEN-D-12-28-106-C
• Device Lot Number: AC1060926
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/26/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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: Required Intervention
• Patient Age: 68 YR