|
Investigation - evaluation: on (b)(6) 2021, cook became aware of a leakage at the connection of two zenith flex with spiral-z technology aaa endovascular iliac leg grafts (rpn: zsle-16-56-zt, lot: 13506930 and rpn: zsle-11-122-zt lot: 13204363).The issue was reported by magnum freight corporation in colombia.No additional intervention was performed.Reviews of documentation including the complaint history, device history records (dhr), drawings, instructions for use (ifu), manufacturing instructions (mi), quality control documents, and specifications of both devices were conducted during the investigation.The complaint devices were not returned; therefore, no physical examinations could be performed.However, a short video clip was provided, confirming the presence of an endoleak.Cook has concluded that the devices were manufactured to specifications.Additionally, a document-based investigation evaluation was performed.A review of the device master records (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history files (dhf) showed that these devices are both safe and effective for their intended use.A review of the dhrs for both reported complaint device lots (13506930 and 13204363) as well as their related graft subassembly lots revealed no recorded nonconformances related to the failure mode.It should be noted that zsle- devices are distributed via one-device lots, giving no indication of nonconforming product in house.A database search did not identify any events related to either device lot.As there are adequate inspection activities in place, there is objective evidence that the dhrs were fully executed, there are no related non-conformances, and there are no other lot-related complaints that have been received from the field, cook has concluded that there is no evidence suggesting non-conforming product exists either in house or in the field.Cook also reviewed product labeling.The product ifu, [t_zaaasz_rev4] ¿zenith® spiral-z aaa iliac leg with the z-trak¿ introduction system¿, provides the following information to the user related to the reported failure mode: "4 warnings and precautions: 4.1 general.Additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.4.2 patient selection, treatment and follow-up.Zenith spiral-z iliac artery distal fixation site greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.4.4 device selection.Strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size.Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.4.5 implant procedure.Appropriate procedural imaging is required to successfully position the zenith spiral-z aaa iliac leg and assure accurate apposition to the vessel wal.Inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.5 adverse events: 5.2 potential adverse events.Adverse events that may occur and/or require intervention include, but are not limited to: endoleak.8 patient counseling information:.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.11 directions for use: 11.1 zenith spiral-z aaa iliac leg system.11.1.7 molding balloon insertion.7.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.9.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand.Final angiogram: 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.12 imaging guidelines and postoperative follow-up: 12.1 general.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.Physicians should evaluate patients on an individual basis and prescribe follow-up relative to the needs and circumstances of each individual patient.The minimum requirement for patient follow-up (described in the instructions for use for the zenith aaa device that was used) should be maintained even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.12.2 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak.¿ based on the available information, no returned products, and the results of our investigation, a definitive root cause was unable to be established.However, it should be noted that endoleaks are a known inherent risk of using zsle- devices.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.
|
