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
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The graft was successfully implanted, only the delivery system is expected to be returned for evaluation.
Event or Problem Description
When releasing the distal end of the graft, the release mechanism came off but the wire did not.Forceps were used to remove wire and the case was completed successfully.
Additional Manufacturer Narrative
The delivery system, sheath, and white release mechanism (including the trigger wire) were returned and evaluated.There were signs of damage to the pusher and the white release mechanism had the screw and wire in place indicating trigger wire breakage.Review of the device history record (dhr) for work order (b)(6) found that the work order appeared complete, and the quality control inspection was verified to ensure that the device passed inspection.Review of specifications found that there are a number of controls and processes in place that would identify faulty product prior to shipping.Review of instructions for use (ifu) supplied with the device for general information was found to contain appropriate warnings, precautions, and instructions to the user, including: 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.(figure 30) 2.Under fluoroscopy and after verification of iliac leg graft position, withdraw grey positioner with secured inner cannula.3.Re-check the position of the wire guides.Leave sheath and wire guide in place.4.Close the captor hemostatic valve on the introducer sheath by turning in a clockwise direction until hemostasis is achieved.(figure 31) note: technical assistance from a cook product specialist may be obtained by contacting your local cook representative.A review of the manufacturing records and specifications did not reveal any discrepancies that could have contributed to the reported issue.The investigation concluded that the complaint device was manufactured to specification.Based on the available information, visual inspection of returned device and completed investigation, a definitive root cause could not be determined.Possible root causes are: inadequate material selection inadequate design patient/procedural factors.
Event or Problem Description
When releasing the distal end of the graft, the release mechanism came off but the wire did not.Forceps were used to remove wire and the case was completed successfully.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: veronica herreraalviar ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 19227057
• Report Number: 9680654-2024-00046
• Device Sequence Number: 15198796
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)270319(10)AC1155383
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1155383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: 61 YR
• Patient Sex: Male