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 G32551

Device Problems Leak/Splash (1354); Material Separation (1562); Device Slipped (1584); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 12/06/2020

Event Type  Injury  

Event Description

The proximal and distal pieces have separated, creating an endoleak.The physician placed a bridging piece (an alpha thoracic piece) to bridge the separation successfully.

Manufacturer Narrative

The device was not returned for evaluation.The william cook australia medical director reviewed the supplied imagining and confirmed the separation between the zfen-p and zfen-d being the cause of the endoleak.Work order ac1008608 was reviewed and appears complete and correct.The ifu 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 of the difficulty reported by the healthcare facility is unknown.

Event Description

The proximal and distal pieces have separated, creating an endoleak.The physician placed a bridging piece (an alpha thoracic piece) to bridge the separation successfully.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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
• MDR Report Key: 11020804
• MDR Text Key: 222006009
• Report Number: 9680654-2020-00043
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)201213(10)AC1008608
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1008608
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 02/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR