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-2-30-124-R

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

Patient Problem Rupture (2208)

Event Date 09/12/2020

Event Type  Injury  

Event Description

Patient had z-fen repair in 2016.Follow up ct's showed abdominal aortic aneurysm (aaa) was shrinking per physician and then patient showed up in the er with a ruptured aorta due to proximal and distal body graft overlap coming apart, and the two components were separated.They did not feel they could gain proximal control easily and opened the patient to repair.Proximal z-fen component stayed intact.Physician removed distal stent of proximal component and sewed aorta bifem to proximal.

Event Description

Patient had z-fen repair in 2016.Follow up ct's showed abdominal aortic aneurysm (aaa) was shrinking per physician and then patient showed up in the er with a ruptured aorta due to proximal and distal body graft overlap coming apart, and the two components were separated.They did not feel they could gain proximal control easily and opened the patient to repair.Proximal z-fen component stayed intact.Physician removed distal stent of proximal component and sewed aorta bifem to proximal.

Manufacturer Narrative

The device was not returned for evaluation.Three unsuccessful requests to obtain additional medical imaging were initiated.The work order was not provided and therefore could not be reviewed against specification.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.Capa (b)(4) was opened to investigate graft separation.This capa is at the 'capa in progress' stage.Based on the information provided, the root cause of the difficulty reported by the customer is unknown.It is possible that the separation was due to: insufficient fixation (friction) between the proximal and distal components.Inadequate retention forces.Distal device separation.Patient-related factors.

• 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
• MDR Report Key: 10570667
• MDR Text Key: 208088884
• Report Number: 9680654-2020-00029
• Device Sequence Number: 1
• Product Code: MIH
• 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: 12/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: ZFEN-P-2-30-124-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR