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	G32542
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The graft was unsheathed after cannulation of the needed vessels and the first trigger (gold) was about to be removed to deploy distal constraining ties.Upon complete removal of the white knob, the physician attempted to pull the wire with the gold trigger release mechanism.Only half of the gold mechanism came off with no wire attached.The physician was instructed by the district manager to pause and look for the wire in the remaining mechanism.The wire was visible and the physician found a surgical clamp to hold the wire while a heavy-duty needle driver to grasp the wire was located.The other half of the gold mechanism was removed.The wire was removed under fluoroscopic guidance while observing full opening of the graft.There were no other issues with the removal of the remaining two release mechanisms.Surgery was completed with not additional actions needed.There does not seem to be any screws in the gold release mechanism that would hold the two parts together with the wire.The district manager has informed that the instructions for use (ifu) was followed.There were no deviation or divergence off the ifu that caused the reported event.This occurred at the distal end of the device and early in the deployment.The patient anatomy was not a factor.Renal fenestrations were added to the graft.The graft was un-sheated and re-sheathed.
Additional Manufacturer Narrative
The device remains implanted, but the delivery system, sheath, trigger wire and gold release mechanism were returned for evaluation.The visual inspection showed that the device was contaminated with biological matter.The inner cannula was severely bent.This was most likely due to the way the device had been packaged when it was returned for evaluation.The visual inspection confirmed that there were no screws in the gold release mechanism.A review of the device history record found that the work order for lot number ac1129431 appears complete and correct and the quality control inspection was verified to ensure the device passed inspection.The specifications were reviewed, and they contain instructions to place screws in the release mechanism.The definitive root cause was related to manufacturing.There was an operator error and the socket head cap screws were missing.An internal action was taken to address the issue.Retraining of all manufacturing staff involved in the steps relevant to the release mechanism was completed.
Event or Problem Description
The graft was unsheathed after cannulation of the needed vessels and the first trigger (gold) was about to be removed to deploy distal constraining ties.Upon complete removal of the white knob, the physician attempted to pull the wire with the gold trigger release mechanism.Only half of the gold mechanism came off with no wire attached.The physician was instructed by the district manager to pause and look for the wire in the remaining mechanism.The wire was visible and the physician found a surgical clamp to hold the wire while a heavy-duty needle driver to grasp the wire was located.The other half of the gold mechanism was removed.The wire was removed under fluoroscopic guidance while observing full opening of the graft.There were no other issues with the removal of the remaining two release mechanisms.Surgery was completed with not additional actions needed.There does not seem to be any screws in the gold release mechanism that would hold the two parts together with the wire.The district manager has informed that the instructions for use (ifu) was followed.There were no deviation or divergence off the ifu that caused the reported event.This occurred at the distal end of the device and early in the deployment.The patient anatomy was not a factor.Renal fenestrations were added to the graft.The graft was un-sheated and re-sheathed.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: 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: majbrit frosig ; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• MDR Report Key: 16892978
• Report Number: 9680654-2023-00025
• Device Sequence Number: 12340295
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)260307(10)AC1129431
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2026
• Device Model Number: G32542
• Device Catalogue Number: ZFEN-P-2-28-124-R
• Device Lot Number: AC1129431
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female