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

Catalog Number ZFEN-D-12-28-76-C

Device Problems Fracture (1260); Defective Component (2292)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

The placement went fine, it was during the removal of the device is when it was noticed that the distal trigger thumbscrew appeared to be sheared off.A saw had to be used to cut the trigger wire in half to remove the distal wire.No harm to patient.Reporter advised that it does not seem that the device inspected prior to use in order to ensure no damage had occurred; due to the thumbscrew being sheared off.Reporter was unable to confirm that the thumbscrews were in place.(wen asked if the thumb screws (rmts) were aligned at 12 o¿clock, and were aligned with the anterior gold markers.) the trigger wire released with the use of a saw to cut the white piece in half and pull the trigger.The alternative trigger wire release method was utilized as per labelling, but 'it would not budge'.

Event Description

The placement went fine, it was during the removal of the device is when it was noticed that the distal trigger thumbscrew appeared to be sheared off.A saw had to be used to cut the trigger wire in half to remove the distal wire.No harm to patient.Reporter advised that it does not seem that the device inspected prior to use in order to ensure no damage had occurred; due to the thumbscrew being sheared off.Reporter was unable to confirm that the thumbscrews were in place.(when asked if the thumb screws (rmts) were aligned at 12 o¿clock, and were aligned with the anterior gold markers.) the trigger wire released with the use of a saw to cut the white piece in half and pull the trigger.The alternative trigger wire release method was utilized as per labelling, but 'it would not budge'.

Manufacturer Narrative

No part of the device was returned for evaluation.No imaging was supplied to assist the investigation.Additional information was received as follows: - how was it discovered and during which step in the ifu was the nonconformance first identified? upon removal - what does the physician think caused the issue? the sheared off screw, from either shipping/packing, as well as the discrepancy not being caught in the preparation steps.- was the device inspected prior to use in order to ensure no damage has occurred? no, it doesn't seem that it was due to the thumbscrew being sheared off.- can you confirm that the thumb screws (rmts) were aligned at 12 o¿clock, and were aligned with the anterior gold markers? can't confirm that the thumbscrews were in place.- by what means was the trigger wire released? by use of a saw to cut the white piece in half and pull the trigger.Was the alternative trigger wire release method utilized as per labelling? yes, but it would not budge.- was there any resistance on withdrawal of the device? if so, was the cause of resistance identified? no - was the graft fully deployed and in desired place prior to withdrawal? yes review of device history record found that the work order for lot ac1149481 appeared complete and correct.The associated inspection record confirms that the device was manufactured to specification.Review of specifications found that there are a number of controls and processes in place that would identify faulty product prior to shipping.The instructions for use (ifu) supplied with the device was found to contain sufficient instructions and guidance including: 9.How supplied 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.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.11.4.8 distal bifurcated body placement 3.Before insertion, position distal bifurcated body delivery system on patient¿s abdomen under fluoroscopy to determine the orientation of the contralateral limb.The side arm of the hemostatic valve may serve as an external reference to the contralateral limb radiopaque marker.11.4.12 distal bifurcated body deployment (continued) 1.Remove the safety lock from the white trigger-wire release mechanism.Withdraw and remove the trigger-wire by sliding the white trigger-wire release mechanism off the handle and then remove via its slot over the device inner cannula.A review of the manufacturing records did not reveal any discrepancies that could have contributed to the reported issue.The investigation concludes the complaint device was manufactured to specification.A definitive root cause could not be determined from the investigation.Possible root causes are: - inadequate material selection - inadequate design - procedural factors - transportation/storage/handling factors.An internal action is not deemed necessary.The mandatory requirement to always check complaints history during a complaint investigation will ensure trends are constantly monitored.After considering this event the benefits of using this device still outweigh the known risks.

• 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 ; 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: 18692514
• MDR Text Key: 336069682
• Report Number: 9680654-2024-00019
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)261221(10)AC1149481
• 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: 04/17/2024

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 Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1149481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2023
• 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