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-2-28-94-R
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was symptomatic and they performed an angiogram.The angiogram revealed that the right renal artery was occluded.The physician said that the right renal artery stent appeared crushed.The crushed stent was a lifestream vascular covered stent manufactured by bard.There did not appear to be any problem with the cook device.However, it is not known if the cook device may have contributed to the damage noted.After the angiogram, the physician attempted to wire the stent and the renal artery.After three hours, he was unable to get into the renal artery.No further additional procedures have ben planned at this time.
Additional Manufacturer Narrative
The device was not returned for evaluation.No imaging was available to assist with the investigation.Additional information was received from the sales representative.It was stated that the physician did not experience any difficulty during the procedure, and that the device was successfully implanted.The sales representative stated that the right renal artery (rra) fenestration lined up with the vessel, and that the rra was not difficult to cannulate.The patient¿s anatomy was not tortuous.The physician had stated that he does not have any input to what could have caused the bard lifestream stent to have been crushed.The physician will no longer use the bard lifestream stents.The medical director assessed the information available and stated that no fault or failure of the zenith fenestrated graft (zfen-p-2-28-94-r) appears to be present.The problem appears to be restricted to the bard lifestream stent.The medical director commented that kidneys move up and down in the body due to respiration.It is therefore feasible that the problem may have been caused by serious coughing which would have put pressure on the stent that may not have been strong enough to withstand the pressure.The medical director noted that it is also possible that the bard lifestream stent was crushed during the implant procedure and that this went unnoticed at the time.The device history record for lot number: ac1131284 was reviewed and the work order appeared complete and the quality control inspection was verified to ensure that the device passed inspection.There were no non-conformances raised or temporary deviations in place at the time of manufacture.A review of the manufacturing records and/or specifications did not reveal any discrepancies that could have contributed to this complaint issue.The investigation concludes the complaint device was manufactured to specification.The instructions for use (ifu) supplied with the device was reviewed and it was found that it contains appropriate warnings, precautions, instructions for proper placement of the device, and adverse events.This is not a confirmed complaint.The medical director assessed this event and agreed with the surgeon that there appears to be no fault or failure of the zenith fenestrated graft, and that the problem is restricted to the bard lifestream stent.Based on the information provided it is not possible to determine the cause that contributed to the lifestream stent to crush.
Event or Problem Description
The patient was symptomatic and they performed an angiogram.The angiogram revealed that the right renal artery was occluded.The physician said that the right renal artery stent appeared crushed.The crushed stent was a lifestream vascular covered stent manufactured by bard.There did not appear to be any problem with the cook device.However, it is not known if the cook device may have contributed to the damage noted.After the angiogram, the physician attempted to wire the stent and the renal artery.After three hours, he was unable to get into the renal artery.Unknown if further additional procedures will be attempted.

• 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: 18167334
• Report Number: 9680654-2023-00139
• Device Sequence Number: 20234456
• Product Code: MIH
• UDI-Device Identifier: 10827002325323
• UDI-Public: (01)10827002325323(17)260403(10)AC1131284
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2026
• Device Catalogue Number: ZFEN-P-2-28-94-R
• Device Lot Number: AC1131284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/19/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male