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 Defective Device (2588); Physical Resistance/Sticking (4012)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

The safety wire wasn¿t coming out and was difficult to release.Upon removing the black trigger wire, it would not release.The more it was pulled on, it would cause the graft to start to collapse.Then, the pin device on the system was released and advanced the inner cannula up in order to remove the black trigger wire.There was no harm to patient and the procedure was completed successfully.

Event Description

The safety wire wasn't coming out and was difficult to release.Upon removing the black trigger wire, it would not release.The more it was pulled on, it would cause the graft to start to collapse.Then, the pin device on the system was released and advanced the inner cannula up in order to remove the black trigger wire.There was no harm to patient and the procedure was completed successfully.

Manufacturer Narrative

Additional information was received that stated the following: the patient did not have any pre-existing conditions related to the event.The nonconformance was first identified during deployment of the bare stent.The graft was placed successfully, and no patient impact was reported as occurring.There was difficulty experienced during deployment- the safety wire wasn't coming out.The patient had some anterior abdominal angulation aortic, and some tortuous iliac on both sides.The physician does not know what caused the issue as this was the first time this has happened.The device was positioned on the patient¿s abdomen, prior to insertion to confirm that the graft was in the correct orientation.The anterior markers aligned with the tick mark, when the gold markers were checked under fluoroscopy prior to insertion into the patient.The thumb screws (rmts) were aligned approx.At 10 o'clock, and not aligned at 12 o¿clock and aligned with the anterior gold markers.The trigger wire was released by unscrewing the thumb screw and pulling back the safety.The alternative trigger wire release method was not utilized as per labelling.The gold markers on the graft aligned as per the ifu and rotated as per the ifu pre-procedure.There was no difficulty positioning graft, and it was possible to align the branches, fenestrations, and scallops with the native vessels.The deployment and branch, fenestrations and scallops¿ alignment were done in stages.The physician was able to land the device in the planned target zone.There was difficulty withdrawing trigger wires- as the black trigger wire would not release.There was difficulty deploying top cap- as the safety wire would not come out.The device was inspected prior to use in order to ensure no damage has occurred.One delivery system was returned for evaluation.Upon visual inspection, it was noted that the trigger wire had a bend in the wire, which could be caused by the resistance reported in the complaint.There were also scratch marks inside the top cap, consistent with difficultly removing the trigger wire and evidence that the bare suprarenal stent got entangled within the top cap.The subject matter expert (sme) assessed the images of the returned device and answered the following: as the manufacturing specification states to cut at an angle, the end of the wire in the photo is not fractured or does not exhibit a normal edge.For the kink that was observed on the wire ¿ the manufacturing specification states to put a slight kink in the wire, (the sme had checked with production to understand if the kink was too much.) the second bend in the wire would have been from the resistance and evidence of it becoming entangled with the bare suprarenal stent within the top cap.There were a couple of scratches inside the top cap and this could have been caused by the kink in the wire.The issue observed might have been due to potential manufacturing problem; as the kink appeared to be more pronounced than would be expected.Further information was received from the sme that stated "i have spoken to production and the kink on the end of the wire is bigger than they are trained to do, the manufacturing specification states ¿using wire cutters at any angle, cut the end of the 0.018" wire to form a point.Make a slight bend at the tip end of the 0.018" wire with the needle holder and insert it into the bevelled hole in the top cap back through the stent loop point with the solder joint where the wire was originally passed through and into the cavity between the cannula and the internal thread of the vrdt as far as it will go".The inspection of the returned device confirmed that the kink on the end of the wire is bigger than it should be as per the manufacturing specifications.The investigation concludes the complaint device was not manufactured to specification.The work order for the lot: ac1141209 was reviewed and appears complete and correct.There were no temporary deviations or non-conformances at the time of manufacturing.The manufacturing specifications were reviewed and found to contain sufficient instructions to manufacture the device.The instructions for use (ifu) supplied with the device was reviewed and states the following: 4.3 implant procedure: the zenith fenestrated aaa endovascular graft incorporates a suprarenal stent with fixation barbs.Exercise extreme caution when manipulating interventional devices in the region of the suprarenal stent.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.Care should be taken not to damage the graft or disturb graft positioning after graft placement in the event re-instrumentation of the graft is necessary.Based on the information provided and evaluation of returned device, the root cause of the reported event was that the bare suprarenal stent got entangled within the top cap, caused by the kink on the end of the wire that was manufactured out of specifications.An internal action has been taken to address the issue: the loading team was notified, and retraining was conducted.This is the first reported event of this nature.After considering this event, the benefits of using this device still outweigh the known risks.

• 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): COOK AUSTRALIA; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• Manufacturer Contact: thejus baby ; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• MDR Report Key: 17920203
• MDR Text Key: 326487441
• Report Number: 9680654-2023-00138
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)260824(10)AC1141209
• 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: 01/18/2024

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-P-2-30-124-R
• Device Lot Number: AC1141209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• 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: 90 YR
• Patient Sex: Male