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

Catalog Number UNKNOWN

Device Problems Device Dislodged or Dislocated (2923); Pressure Problem (3012)

Patient Problems Death (1802); Rupture (2208); Ruptured Aneurysm (4436)

Event Type  Death  

Event Description

Loss of junctional overlap between the proximal main body and the distal bifurcated piece resulting in sac pressurization, rupture, and death.Date of event unknown [the study covers between october 2012 and march 2019- article published 29 may 2020].'perioperative and long-term results of zenith fenestrated aortic repair in women' liao et al 2019.Although the title of the article names women the adverse event reported was for a male patient.

Event Description

Loss of junctional overlap between the proximal main body and the distal bifurcated piece resulting in sac pressurization, rupture, and death.Date of event unknown [the study covers between october 2012 and march 2019- article published 29 may 2020].'perioperative and long-term results of zenith fenestrated aortic repair in women' liao et al 2019.Although the title of the article names women the adverse event reported was for a male patient.

Manufacturer Narrative

The device was not returned for evaluation.As a lot number and device type could not be provided, a review of the device history record could not be performed.The ifu reviewed for general information only 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" for patients who are experiencing enlarging aneurysms, an unacceptable decrease in fixation length (vessel and component overlap), or endoleak after the initial endovascular repair, consider additional endovascular interventions or conversion to standard open surgical repair.An increase in aneurysm size or persistent endoleak may lead to aneurysm rupture."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.Due to the lack of information received in the complaint it is difficult to determine a definitive root cause.

• Brand Name: ZENITH FENESTRATED GRAFT
• 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: 11210693
• MDR Text Key: 228156645
• Report Number: 9680654-2021-00004
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death