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	G32554
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a procedure on (b)(6) 2018 to repair an abdominal aneurysm.A zfen-p-2-34-137-r (lot ac1025994), zfen-d-12-28-91-c (lot ac1025995), zsle-13-56-zt (lot 8966438), and zsle-16-56-zt (lot 9037918) were placed.A type 4 endoleak was noted and appears to be with the left common iliac.A zsle-13-39-zt (lot 8409848) was placed to reline.The physician decided to wait 30 days for the endoleak to resolve.The endoleak did not resolve on its own.On (b)(6) 2019 the physician went in to see if a cook cuff could be placed as the leak was now believed to be above flow divider at the distal graft.Focal leak could not be identified on cta or selective angiograms, so the fevar stent was 80% relined with bilateral two gore limbs and a gore cuff.Endoleak persisted a month later and still appeared diffuse, so stent was relined a second time up to renal fenestrations and converted to aorto-uni-iliac and fem-fem, which resulted in complete resolution of leak.Patient continues to do well after complete relining with no further endoleaks.
Additional Manufacturer Narrative
The device was not returned for evaluation and remains in-situ.Medical imaging was supplied and reviewed by the william cook australia medical director.The medical director stated there are only the pre-op imaging, and the first post-op imaging.The post-op ct scan shows a large but very diffuse endoleak around the distal part of the graft.This comprises the zfen-d plus two zsle iliac limbs.It was difficult to identify where the leak is originating, which supports it being a type 4 endoleak due to porosity through the fabric of the graft.However, the leak did not settle down spontaneously, and most type 4 endoleaks do settle down once the anticoagulation of the patient has been reversed or worn off.This one didn¿t settle down, and also didn¿t settle after initial re-lining with gore components.It took complete re-lining for a second time, all the way up to the renals, and conversion to an aorto-uni-iliac graft before the leak settled.Work order (b)(4) was reviewed and appears to be complete and correct.The device ifu states: "endoleak" is listed as a potential adverse event."patients with specific clinical findings (e.G.,endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up" "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.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up" based on the information in the complaint, it is difficult to identify a root cause.There is no evidence to indicate that a device non-conformance of deficiency contributed to the complaint.
Event or Problem Description
The patient underwent a procedure on (b)(6) 2018 to repair an abdominal aneurysm.A zfen-p-2-34-137-r (lot ac1025994), zfen-d-12-28-91-c (lot ac1025995), zsle-13-56-zt (lot 8966438), and zsle-16-56-zt (lot 9037918) were placed.A type 4 endoleak was noted and appears to be with the left common iliac.A zsle-13-39-zt (lot 8409848) was placed to reline.The physician decided to wait 30 days for the endoleak to resolve.The endoleak did not resolve on its own.On (b)(6) 2019 the physician went in to see if a cook cuff could be placed as the leak was now believed to be above flow divider at the distal graft.Focal leak could not be identified on cta or selective angiograms, so the fevar stent was 80% relined with bilateral two gore limbs and a gore cuff.Endoleak persisted a month later and still appeared diffuse, so stent was relined a second time up to renal fenestrations and converted to aorto-uni-iliac and fem-fem, which resulted in complete resolution of leak.Patient continues to do well after complete relining with no further endoleaks.

• 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: 9120811
• Report Number: 9680654-2019-00037
• Device Sequence Number: 16902076
• Product Code: MIH
• UDI-Device Identifier: 10827002325545
• UDI-Public: (01)10827002325545(17)211023(10)AC1025995
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/08/2019

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: 10/23/2021
• Device Model Number: G32554
• Device Catalogue Number: ZFEN-D-12-28-91-C
• Device Lot Number: AC1025995
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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: 76 YR