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-2-30-109-R

Device Problems Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

During a zfen case the black trigger wire was extremely difficult to remove.It was bowing the delivery system.It took the surgeon several attempts to do remove it.Iliacs were not tortuous.Preservation of the viscerals (renals & sma) and integrity of device not impacted.Patient¿s aaa was properly treated with proper seal.

Manufacturer Narrative

The graft was successfully implanted, the black trigger wire and the grey delivery system are expected to be returned for evaluation.

Manufacturer Narrative

The graft had been successfully implanted.No imaging was supplied to assist the investigation.The customer returned the delivery system and a black trigger wire for evaluation.The following observations were made during inspection: the device was contaminated with biological matter.The inner cannula was bent.There was no evidence of scratch marks on the white handle.The proximal end of the black trigger wire was bent.Damage was observed on the pusher indicating resistance during deployment.The top cap was opened to inspect the inner surface and the evaluation confirmed presence of scratch marks.Review of device history record for lot ac1146568 found the work order appeared complete, and the quality control inspection record was verified to ensure that the device passed inspection after some reworking of the device to correct non-conformance's related to gold marker positioning discovered during quality control inspections.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: 11.4 fenestrated system: 13.Remove the safety lock from the top stent trigger-wire release mechanism.Under fluoroscopy, withdraw and remove the triggerwire to unlock the suprarenal stent from the top cap by sliding the black trigger-wire release mechanism off the handle and then remove via its slot over the inner cannula.If resistance is felt or system bowing is noticed, the trigger-wire is under tension.Excessive force may cause the graft position to be altered.If excessive resistance or delivery system movement is noted, stop and assess the situation.If unable to remove the black trigger-wire release mechanism from the top cap, perform the following steps under fluoroscopy: a.Remove tension on the trigger-wire by loosening the pin vise and slightly pulling the inner cannula to move the top cap down over the suprarenal stent.Avoid compressing the zenith fenestrated proximal body.B.Retighten the pin vise.C.Remove the black trigger-wire release mechanism.There is no evidence to suggest that the user did not follow the instructions for use.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.A definitive root cause could not be determined from the investigation.Possible root cause(s) are: wire jammed within top cap; procedural 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.

Event Description

During a zfen case the black trigger wire was extremely difficult to remove.It was bowing the delivery system.It took the surgeon several attempts to do remove it.Iliacs were not tortuous.Preservation of the viscerals (renals & sma) and integrity of device not impacted.Patient¿s aaa was properly treated with proper seal.

• 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: 18361671
• MDR Text Key: 331073079
• Report Number: 9680654-2023-00146
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325385
• UDI-Public: (01)10827002325385(17)261113(10)AC1146568
• 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-P-2-30-109-R
• Device Lot Number: AC1146568
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• 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: 71 YR
• Patient Sex: Male