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

Catalog Number ZFEN-P-2-28-109-R

Device Problems Material Separation (1562); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/06/2022

Event Type  Injury  

Event Description

The proximal and distal main body's separated resulting in a total occlusion.Attempted to suck the clot out and bridge the separation.The bridging procedure was conducted, but the physician couldn't get all the clot out.

Manufacturer Narrative

No part of the device was returned for evaluation.No images were available for evaluation.The medical director reviewed the information supplied in the complaint as no imaging was received and confirmed the graft separation between the zfen-p and zfen-d.The separation was noted in (b)(6) 2022 and was not able to be bridged successfully.The medical director stated: "in most cases, the separation results in a large endoleak, leading to aneurysm expansion and often rupture, sometimes with the patient¿s death.In this case, the conduit thrombosed causing complete occlusion.Thrombectomy was performed, although they couldn¿t get all the clot out, and a re-lining bridging sleeve was used to bridge the gap between the zfen-p and the zfen-d.The usual cause of this problem is that the us-spec zfens have equal diameter for the distal zfen-p and the proximal zfen-d.In other words, it is a ¿slip fit¿ of the distal component into the proximal component.If the amount of overlap is inadequate as well, then separation is likely to occur over time, particularly in large aneurysms where the endograft can ¿bow¿ or arch forwards or sideways, in which case the distal component simply pulls out of the proximal component".Work order review could not be completed as the lot number is unknown.The instructions for use [ifu] supplied with the complaint device states: that the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established, and 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.Potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak, component migration.Based on the information provided, the root cause could not 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.A capa was raised to address concerns of separation for the zfen-us devices.The capa determined "the conclusion of the investigation was that there is no fault/non-conformance of the us fen device, its labelling, its ifu, its manufacturing, nor its clinical use.The zfen us configuration meets the acceptance criteria for this product and the acceptance criteria are deemed acceptable.".

Event Description

The proximal and distal main body's separated resulting in a total occlusion.Attempted to suck the clot out and bridge the separation.The bridging procedure was conducted, but the physician couldn't get all the clot out.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: 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: 15024236
• MDR Text Key: 295952966
• Report Number: 9680654-2022-00011
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 09/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male