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As reported by terumo japan via its complaints department located in (b)(6): ¿aneurysm ruptured: on (b)(6) 2024, treatment for a right va aneurysm (size unknown) was performed on the patient who was raced to the hospital with an impending rupture.The patient was treated as a semi-emergency case.While the first fred stent was being half deployed, the first coil (target xl, stryker) was implanted in the aneurysm.After the implantation of the first coil, the fred stent was fully deployed.The second and third coils (i-ed coil, kaneka) were then placed.The coils were implanted clumped together in the lower part of the aneurysm and only about two loops of coil were located in the upper part of the aneurysm.Angiography after placement of three coils confirmed that the aneurysm had ruptured.(the rupture was presumed to have occurred in the upper part of the aneurysm) attempts for hemostasis was performed using a balloon, but the bleeding could not be stopped.The second fred stent was implanted so that it overlapped completely within the first stent.The third stent (mv-f351127) was also implanted within the previously implanted stents.As the hemorrhage was still unable to be stopped, the fourth stent (mv-f351127) was additionally implanted so that it overlapped completely within the previously implanted stents.It was then discovered that hemostasis was successfully achieved.The procedure was terminated as the venous flow was sharply compromised.Decompressive craniectomy was performed on the night of (b)(6) (presumably to relieve cerebral oedema).The patient died.Date of death is unknown.¿ on (b)(6), the sales representative visited the facility and was informed by the treating physician, dr.(b)(6) that the patient had died.The report continues: ¿[dr.(b)(6)] comment on the health damage to the patient: ¿the physician does not believe that the fred stent was the cause of this event.Immediately after the operation, the physician believed that the placement of the coils contributed to the rupture of the aneurysm, but was unable to determine the cause.After reviewing the intra-operative video, the physician believed that placement of the fred stents likely caused jet blood flow into the aneurysm, which caused the aneurysm rupture.¿ comment regarding causal relationship: ¿the physician does not believe that the fred stent was defective but believes that blood flow into the aneurysm sharply increased due to the implantation of the fred stent, causing the aneurysm rupture, which resulted in the patient¿s death.¿ additional information: medical history: none; no image available; no additional information to be obtained; primary disease: cerebral aneurysm; cause of death: cerebral aneurysm rupture; stent implantation site; aneurysm location: ica, c1; side branch vessel covered; size: unknown; ruptured; shape: saccular; lesion site: right side; parent vessel diameter: 3.2 mm on the proximal side and 3.0 mm on the distal side.Antiplatelet and anticoagulant therapy: preoperative: administered, aspirin, clopidogrel; postoperative: unknown.Platelet reactivity test: performed; verifynow pru testing: performed (blood sampling: (b)(6) 2024); pru: 200; other: not performed; poba: not performed¿.
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Items returned: n/a.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in lieu of a device return.Procedure and medical imaging were not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate the presence of any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Ifu review (additional information can be found in the ifu): please refer to the japanese ifu for precautions, warnings, and further information.The following is taken from the english version: potential complications: possible complications include but are not limited to the following: ¿ bleeding or hemorrhage including intracerebral, retroperitoneal or other locations complications of arterial puncture including pain, local bleeding (hematoma) or injury to the artery or adjacent nerves, device migration, distal embolization, headache, incomplete aneurysm occlusion, neurologic deficits including stroke and/or death, perforation or dissection of the vessel(s), pseudoaneurysm formation, rupture or perforation of aneurysm, transient ischemic attack (tia) or ischemic stroke, vasospasm, vessel occlusion, vessel stenosis or thrombosis, warnings: should unusual resistance be felt at any time during access or removal, the introducer/guide catheter/microcatheter and fred system should be removed as a single unit.Applying excessive force during delivery or retrieval of the fred system can potentially result in loss or damage to the device and delivery components.It is imperative to use the fred system with a.027 inch (0.69 mm) inner diameter headway® 27 microcatheter.If repeated friction is encountered during fred system delivery, verify microcatheter is not kinked or in extremely tortuous anatomy.Confirm that the microcatheter does not ovalize.Confirm that there is adequate sterile heparinized flush solution.Do not reposition the fred system in the parent vessel without fully retrieving the device.The fred system must be retrieved/resheath into the microcatheter and re-deployed at the desired target location or removed completely from the patient.Cautions: exercise caution when crossing the deployed/detached fred system with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement.Directions for use (¿) advance the delivery wire to transfer the fred system from within the introducer into the microcatheter.Warning: do not torque the delivery wire while advancing or retracting the fred system.Continue advancing the delivery wire into the microcatheter until the proximal tip of the delivery wire enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Warning: do not apply undue force.If resistance is encountered at any point during delivery or manipulation, withdraw the unit and select a new fred system.(¿) position the fred system for deployment by aligning the fred system implant distal radiopaque end markers approximately 7 mm past the aneurysm neck.[figure 7] note: a slow, proper push/pull technique, encompassing sufficient delivery wire push force, in addition to an opposing microcatheter withdrawal force, to remove excess microcatheter slack while maintaining the microcatheter tip within the center of the parent vessel, will facilitate properly deploying the fred system at the proper location, to achieve full expansion and good vessel apposition.Caution: using a rapid microcatheter withdrawal technique to deploy the fred system is not recommended and may result in device elongation or improper deployment.Be aware of delivery wire tip position during deployment.If fred system positioning is not satisfactory, the fred system implant may be recaptured and repositioned if it is not fully deployed.The implant may be recaptured until the point where the distal-most wire marker, collocated distal to the implant proximal markers, is aligned approximately 50% of length proximal to the microcatheter distal marker band.[figure 8] caution: if resistance is felt while recapturing the device, do not continue to recapture.Withdraw the microcatheter slightly to unsheath the device (without exceeding the recapture limit), and then attempt to recapture again.Caution: the fred system must not be re-deployed more than three times.Caution: the fred system delivery wire should not be utilized as a guidewire.Do not torque the fred system.A torque device should not be used.If fred system positioning is satisfactory, carefully advance the delivery wire while retracting the microcatheter as needed to minimize slack, maintaining the microcatheter around the center of the parent vessel, to allow the implant to deploy across the neck of the aneurysm.Ensure the implant proximal radiopaque end markers are approximately 7 mm proximal to the aneurysm neck to ensure an adequate coverage.Note: the fred system will expand and may foreshorten up to 60% from its undeployed length.Note: visualize and refer to implant radiopaque end markers to maintain adequate implant length of approximately 7 mm on each side of the aneurysm neck/target location to ensure appropriate coverage.[figure 7] warning: do not detach the fred system if it is not properly positioned in the parent vessel.Warning: if applicable, observe fred system marker position during coiling procedure to ensure that the device does not migrate.(¿) carefully inspect the deployed fred implant under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the implant is not fully apposed or is kinked, consider utilizing a suitable microguidewire and/or occlusion balloon catheter to fully open the implant.Verify that the implant remains patent and properly positioned.Note: the jailed microcatheter should be carefully removed to avoid dislodging the fred system implant.Caution: carefully watch the fred system implant distal and proximal markers when passing through the implanted device with other devices to avoid displacing the implant.¿ the physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.Microvention is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by microvention, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Microvention has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, microvention, or its employees that the device, microvention, or its employees caused or contributed to the event described in the report.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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