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E1 - customer (person): phone: (b)(6), postal code: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d6 a (implant date), d10.Correction: a3.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation-evaluation it was reported to cook that a zenith flex with spiral-z technology aaa endovascular graft iliac leg was too short.The 80-year-old male patient underwent an endovascular aortic repair (evar) on (b)(6) 2024.The patient did not have any obvious tortuosity or calcium that would prevent the deployment of the grafts.During the procedure the clinician determined that the appropriate size for implantation was 107 mm long.A zenith flex with spiral-z technology aaa endovascular graft iliac leg was deployed.However, during the implant procedure it was discovered that the total length of the iliac leg graft barely reached 100 mm.It was too short and could not land or seal the desired amount of the artery.An additional zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn:zsle-11-90-zt ) was deployed as an iliac extension.The additional device was not included in the initial planning for the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control, specifications, manufacturing instructions (mi), and instructions for use (ifu) of the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot did not reveal any non-conformances.A complaint history did not identify any additional complaints for this lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: ¿4.2 patient selection, treatment and follow-up ¿ all lengths and dimeters of the devices necessary to complete the procedure should be available to the physician, especially when preoperative planning measurements (treatment diameters/lengths) are not certain.This approach allows for greater intraoperative flexibility to achieve optimal procedural outcomes.Lenths utilizing ct, length measurements should be determined to accurately assess length as well as planning zenith spiral-z aaa iliac leg components.These reconstructions should be performed in sagittal, coronal, and 3-d.5.2 potential adverse events ¿ endoleak ¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; and corrosion 7.1 individualization of treatment cook recommends that the zenith spiral-z aaa iliac leg diameters be selected as describes in table 10.5.1.All lengths and dimeters of the devices necessary to complete the procedure should be available to the physician, especially when preoperative case planning measurements (treatment diameters/lengths) are not certain.This approach allows for greater intraoperative flexibility to achieve optimal procedural outcomes.The risks and benefits should be carefully considered for each patient before use of the zenith spiral-z aaa iliac leg.10.5 device diameter sizing guidelines the choice of diameter should be determined from the outer wall to outer wall vessel diameter and not the lumen diameter.Undersizing or oversizing may result in incomplete sealing or compromised flow.Table 10.5.1 spiral-z aaa iliac leg graft sizing guide intended iliac vessel diameter (mm) : 9 iliac leg diameter (mm): 11 iliac leg label length (mm) : 39, 56, 74, 90, 107, 122 introducer sheath (fr): 14 there is a note stating the following ¿overall leg length = label length +/- 22 mm docking stent¿ ¿ preoperative imaging as well as planning and sizing was provided for the investigation.The image reviewer noted: ¿1.The complaint of a shorter than expected zsle-11-107 deployed length is not confirmed as imaging of the event was not provided.2.The planning measurements match an unrealistically straight path through a capacious and anteriorly angulated aaa.Simulation of a more realistic path demonstrates that a zsle-11-107 inserted to the flow divider would have landed short of a seal zone.Any additional endograft shortening or tortuosity introduced during implantation would also have resulted in an insufficient seal length at intermediate zlse positions within the tffb gate.¿ based on the information provided, an expert review of imaging and the results of the investigation, a potential root cause for this event may have patient anatomy.The image reviewer noted that based on the planning measurements provided, the devices chosen would have matched an unrealistically straight path.The patient¿s anterior angulated abdominal aortic aneurysm was not considered in the planning and would have resulted in an insufficient seal.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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