| Catalog Number |
MFR181137 |
| Medical Device Problem Codes |
Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Positioning Problem (3009)
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| Health Effect - Clinical Codes |
Stroke/CVA (1770); Thromboembolism (2654); No Code Available (3191)
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| Date of Event |
08/21/2019
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Manufacturing site name: (b)(4).Patient codes: no code available, was selected, however, the user intended to place another stent to secure the coil to the vessel wall but couldn¿t advance the mc past the coil mass.Also, the cerebral clot was treated with integrilin and 2mg of tissue plasminogen activator (tpa).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01167.Investigation summary: one non-sterile unit micrusframe18 11mm x 37cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found with no damages on it.The introducer was inspected, and it was found partially unzipped and kinked.The re-sheathing tool was inspected, and it was found in good conditions.Also, the marker band was found at 72cm from hub, and it was found within specification.The v-notch was inspected under microscope and no damages were note on it.The rh was inspected under microscope and it was found heated.The embolic coil was not returned for evaluation.A manufacturing record evaluation was performed for the finished device l12454 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - premature detachment-in microcatheter¿ was confirmed due the rh was found heated, however the condition noted on the rh indicate that the detach button was pressed but the exact time when this happened cannot be conclusively determined.The complaint reported by the customer ¿coil - positioning difficulty-coil herniation¿ could not be evaluated because it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.The complaint reported by the customer ¿coil - protrusion into parent vessel¿ could not be evaluated because it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.The kinked condition appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.
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Event or Problem Description
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As reported by a healthcare professional, during a stent-assisted coil embolization of an anterior communicating artery (acom) aneurysm, an atlas stent was placed from the left side and an 11mm x 37cm micrusframe18 coil was then fully deployed into the aneurysm sac, but the coil mass partially herniated into the parent vessel.Additional 6f access was obtained at the right femoral artery.The physician attempted to pass a microcatheter from the right internal carotid artery (ica) to the opposite anterior cerebral artery (aca) vessel to place a second atlas stent, but the coil mass was in the path of the microcatheter.The physician then attempted to remove the coil to place the stent across the opposite aca, but the coil could not be pulled back into the sl-10 (stryker) microcatheter because it had prematurely detached in the microcatheter.The physician had planned on detaching the coil after deploying the second atlas stent, but he was unable to advance the microcatheter past the coil mass into the other a1 branch.The coil was left partially protruding from the aneurysm into the parent artery, resulting in left a2 clot formation.The clot was treated with integrilin and 2mg of tissue plasminogen activator (tpa).Additional coils were implanted in the aneurysm without incident and the case was concluded.No known further patient complications have occurred.During the same procedure, an 8mm x 30cm micrusframe18 (mfr180830/l10903) device positioning unit (dpu) wire would not advance through the rotating hemostasis valve (rhv) and hub of the unspecified microcatheter.The coil and microcatheter were removed from the patient as a unit, and the same microcatheter was used to re-access the aneurysm with a same-sized replacement coil.No further information was provided.
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Additional Manufacturer Narrative
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(b)(4).Section b5: additional information received indicated that the size of the aneurysm neck (6.81mm) may have contributed to the coil herniation.The aneurysm height was 8.36mm, width was 12.52mm, and depth was 11.19mm.The parent vessel diameter was 2.14mm.The event resulted in a clinically significant procedural delay and there was evidence of distal thrombus embolization.The delay was deemed significant because of the time it took to gain additional access and attempt to place another stent in the opposite a1; however, the aneurysm was considered successfully treated.There was no issue with the coil conforming to the vessel wall.The coil delivery system and concomitant microcatheter were removed from the patient without patient injury or the need for additional intervention.Excessive force had not been applied.Activated clotting times (acts) were measured but the results are unknown.Procedural imaging and the dictated summary operative report were not provided.No further information could be obtained.Further clarification was received that the procedural delay was considered clinically significant because the coil had prematurely detached, and the physician could not pass the sl-10 microcatheter past the coil mass into the opposite aca.The condition of the patient at baseline and post-procedure was not reported.The patient had a partially flow-limiting clot that was treated with iv tpa and integrilin, but the patient was discharged without any deficit.No additional intervention was performed for the thromboembolism.Based on the additional information, section h6 (patient code) was updated with thromboembolism.The investigation summary was updated as further analysis was performed on the micrusframe18 11mm x 37cm.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01168, 3008114965-2019-01167 and 3008114965-2019-01188.Complaint conclusion: as reported by a healthcare professional, during a stent-assisted coil embolization of an anterior communicating artery (acom) aneurysm, an atlas stent was placed from the left side and an 11mm x 37cm micrusframe18 coil was then fully deployed into the aneurysm sac, but the coil mass partially herniated into the parent vessel.Additional 6f access was obtained at the right femoral artery.The physician attempted to pass a microcatheter from the right internal carotid artery (ica) to the opposite anterior cerebral artery (aca) vessel to place a second atlas stent, but the coil mass was in the path of the microcatheter.The physician then attempted to remove the coil to place the stent across the opposite aca, but the coil could not be pulled back into the sl-10 (stryker) microcatheter because it had prematurely detached in the microcatheter.The physician had planned on detaching the coil after deploying the second atlas stent, but he was unable to advance the microcatheter past the coil mass into the other a1 branch.The coil was left partially protruding from the aneurysm into the parent artery, resulting in left a2 clot formation.The clot was treated with integrilin and 2mg of tissue plasminogen activator (tpa).Additional coils were implanted in the aneurysm without incident and the case was concluded.No known further patient complications have occurred.During the same procedure, an 8mm x 30cm micrusframe18 (mfr180830/l10903) device positioning unit (dpu) wire would not advance through the rotating hemostasis valve (rhv) and hub of the unspecified microcatheter.The coil and microcatheter were removed from the patient as a unit, and the same microcatheter was used to re-access the aneurysm with a same-sized replacement coil.A 4mm x 6cm micrusframe14 coil was used but the tab to unlock the coil broke.A hemostat was utilized to manually pull the tab from the green unlocking tool.The coil was not used in the patient.The devices will be returned for analysis.Additional information received on (b)(6) 2019 indicated that the size of the aneurysm neck (6.81mm) may have contributed to the coil herniation.The aneurysm height was 8.36mm, width was 12.52mm, and depth was 11.19mm.The parent vessel diameter was 2.14mm.The event resulted in a clinically significant procedural delay and there was evidence of distal thrombus embolization.The delay was deemed significant because of the time it took to gain additional access and attempt to place another stent in the opposite a1; however, the aneurysm was considered successfully treated.There was no issue with the coil conforming to the vessel wall.The coil delivery system and concomitant microcatheter were removed from the patient without patient injury or the need for additional intervention.Excessive force had not been applied.Activated clotting times (acts) were measured but the results are unknown.Procedural imaging and the dictated summary operative report were not provided.Additional information received on (b)(6) 2019 indicated that the procedural delay was considered clinically significant because the coil had prematurely detached, and the physician could not pass the sl-10 microcatheter past the coil mass into the opposite aca.The condition of the patient at baseline and post-procedure was not reported.The patient had a partially flow-limiting clot that was treated with iv tpa and integrilin, but the patient was discharged without any deficit.No additional intervention was performed for the thromboembolism.One non-sterile unit micrusframe18 11mm x 37cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found with no damages on it.The introducer was inspected, and it was found partially unzipped and kinked.The re-sheathing tool was inspected, and it was found in good conditions.Also, the marker band was found at 72cm from hub, and it was found within specification.The v-notch was inspected under microscope and no damages were note on it.The rh was inspected under microscope and it was found not heated.However, the embolic coil was not returned for evaluation.The extension coil was inspected under microscope and it was found elongated.The resistance of the device was measured with multimeter and enpower control cable lab sample.Resistance initially measured approximately 52.4 o, which is in of the specification range.The device was then inspected under a microscope.The distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - premature detachment-in microcatheter¿ was confirmed due the rh and the embolic coil showed evidence that it had been detached mechanically also the embolic coil was not returned for analysis.The complaint reported by the customer ¿coil - positioning difficulty-coil herniation¿ could not be evaluated because it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.The complaint reported by the customer ¿coil - protrusion into parent vessel¿ could not be evaluated because it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.The elongated condition noted on the extension coil appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Coil protrusion into the parent vessel, premature detachment, thrombosis, and distal thromboembolism are known potential complications associated with coil embolization procedures.The root cause of the coil herniation cannot be conclusively determined based on the minimal information available and without procedural films to review; however, wide-necked giant aneurysms are difficult to treat and may be prone to coil protrusion.Coil protrusion may necessitate coil retrieval or stent deployment in the parent artery.The root cause of the premature detachment cannot be conclusively determined, but excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of premature detachment.Thrombus associated with devices within the aneurysm (coil herniation) is a known potential patient consequence.Assignment of root cause for the event remains speculative and inconclusive; however, it appears that clinical and procedural factors, including aneurysm/vessel characteristics (i.E.Neck size), device selection, device interaction, and device manipulation, may have contributed.The file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
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