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 G32537

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

Upon deployment and attempted removal of the black trigger wire, the trigger wire would not release from the top cap and the graft was being pulled down and crunched in an accordion-like manner.Repeated attempt to deploy were unsuccessful.Manual deployment was completed (with white trigger wire) with use of kelly clamps to release the bottom of graft followed by manual deployment of the black trigger wire and deployment of the suprarenal top cap.The graft was able to be reformed but not entirely.The procedure was completed successfully.

Event Description

Upon deployment and attempted removal of the black trigger wire, the trigger wire would not release from the top cap and the graft was being pulled down and crunched in an accordion-like manner.Repeated attempt to deploy were unsuccessful.Manual deployment was completed (with white trigger wire) with use of kelly clamps to release the bottom of graft followed by manual deployment of the black trigger wire and deployment of the suprarenal top cap.The graft was able to be reformed but not entirely.The procedure was completed successfully.

Manufacturer Narrative

No part of the device was returned for evaluation.Additional information was requested, but no further information was received.No imaging was received to assist the investigation.During a review of manufacturing records, the work order appeared complete, and the quality control inspection was verified to ensure that the device passed inspection.There were no non-conformance's raised or temporary deviations in place at the time of manufacture.A review of specifications did not reveal any discrepancies that could have contributed to this occurrence and found that there are a number of processes and checks in place which would likely identify a device deficiency prior to shipment.Review of the instructions for use (ifu) supplied with the device found that it contained appropriate warnings, precautions, and instructions to the user, including: 4.3 implant procedure ¿ maintain wire guide position during delivery system insertion.¿ fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.¿ 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).¿ do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance.Vessel or catheter damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.¿ take care during manipulation of catheters, wires and sheaths within an aneurysm.Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization.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 material selection ¿ wire entanglement within the system ¿ wire jammed within top cap ¿ high friction interaction with adjacent materials ¿ tortuosity in trigger wire path within the delivery system ¿ patient/procedural 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 ; 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: 17132116
• MDR Text Key: 317489278
• Report Number: 9680654-2023-00039
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)260509(10)AC1133582
• 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: 08/08/2023

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: G32537
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Device Lot Number: AC1133582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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: 69 YR
• Patient Sex: Male