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

Model Number G32547

Device Problems Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Event Description

While orienting the device outside of patient's body under fluoro, it was noted to be 'candy-wrapped' the lra fenestration appeared to be pulled around and superimposed under the rra fenestration.All of the struts were tilted and twisted.The user decided to move forward and advanced the device into the patient.They used several images and orientation techniques while unsheathing and untwisting - finally getting it anterior and straight.

Manufacturer Narrative

No part of the device was returned for evaluation.No imaging was received to assist the investigation.A review of the manufacturing records and specifications did not reveal any discrepancies that could have contributed to the reported issue.There are a number of controls and checks in place to ensure the graft had been loaded appropriately.The manufacturing team was made aware of this occurrence.Review of the instructions for use (ifu) supplied with the device found that it contained appropriate warnings, precautions, and instructions to the user, including: 10.2 'inspection prior to use' "inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to your cook representative or your nearest cook office.Prior to use, verify correct devices (quantity and size) have been supplied for the patient by matching the device to the order prescribed by the physician for that particular patient".11.4.5 'proximal body placement' "4.Before insertion, position proximal body delivery system on patient¿s abdomen under fluoroscopy to assist with orientation and positioning.Rotate to a position where the anterior markers are situated in the most anterior (12:00 o¿clock) position.The sidearm of the hemostatic valve may serve as an external reference to the fenestration(s) and/or scallop(s), anterior and posterior markers and body side markers".Caution: maintain wire guide position during delivery system insertions.Caution: to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).There is no evidence to suggest that the user did not follow the instructions for use.A definitive root cause could not be determined from the investigation.Possible root cause(s) are: inadequate design.Transportation.

Event Description

While orienting the device outside of patient's body under fluoro, it was noted to be 'candy-wrapped' the lra fenestration appeared to be pulled around and superimposed under the rra fenestration.All of the struts were tilted and twisted.The user decided to move forward and advanced the device into the patient.They used several images and orientation techniques while unsheathing and untwisting - finally getting it anterior and straight.

• 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 ; AS
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 17132115
• MDR Text Key: 317489323
• Report Number: 9680654-2023-00038
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325477
• UDI-Public: (01)10827002325477(17)260427(10)AC1132941
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G32547
• Device Catalogue Number: ZFEN-P-2-34-122-R
• Device Lot Number: AC1132941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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 Age: 65 YR
• Patient Sex: Male