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Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Device manufacturing date: unavailable, will be submitted on the next report.The product remains implanted and is thus not available for evaluation and testing.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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As reported by an affiliate, during an intracranial aneurysm embolization procedure, an 2x8 orbit helical fill coil (637hf0208, 17760948) stretched and remained in v4 segment of the left vertebral artery, resulting in cerebral ischemic stroke of the patient.The patient was placed in the intensive care unit (icu).Additional information received indicated that the patient¿s current condition is stable.It is unknown if symptoms resolved or if there are residual symptoms.It is unclear how the procedure was completed but it was reported that follow up intervention is required.The stretching of the coil occurred during positioning/repositioning.The coil protruded into the parent artery.No excessive force had been applied to the device.The unknown concomitant device(s) did not function as expected.Procedural images are not available.
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Product complaint # (b)(4).Section b5: additional information received indicated that the coil stretched, prematurely detached, and then protruded into the parent artery.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an intracranial aneurysm, the 2mm x 8cm trufill orbit helical fill (637hf0208/17760948) coil stretched and remained in the v4 segment of the left vertebral artery, resulting in cerebral ischemic stroke.The patient remains hospitalized in the intensive care unit (icu).No further information was provided at the time of complaint initiation.Additional information received on 10-jul-2019 indicated that the embolic coil stretched during positioning/repositioning and protruded into the parent artery.The coil did not migrate away from the target aneurysm.Follow-up interventions are required, but no further details were provided.The patient is currently in stable condition.Excessive force had not been applied to the device.It was reported that the concomitant devices did not function as expected.Clarification was requested.Additional information received on 24-jul-2019 indicated that the coil stretched, prematurely detached, and then protruded into the parent artery.No further information could be obtained.The device has not been returned for analysis and therefore no further investigation can be performed at this time.A manufacturing record evaluation was performed for the finished device 17760948 number, and no non-conformances related to the reported complaint condition were identified.Coil stretching, premature detachment, protrusion into parent vessel, arterial occlusion, and stroke are known potential complications associated with the use of the device and in coil embolization procedures.The instructions for use (ifu) warns the user to never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.If coil repositioning is required, gently withdraw and then re-advance the coil.If coil repositioning in the vasculature is required, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil during retraction.Although the coil is stretch resistant, failure of the delivery tube and the coil to retract at the same rate indicates that the coil may have stretched which could lead to premature detachment or coil fracture.If a one-to-one relationship does not exist, remove the infusion catheter and the coil as an assembly and replace.If desired placement or stability cannot be achieved, the coil must be removed from the patient.The root cause of the event cannot be conclusively determined based on the limited information available and without procedural imaging to review; however, it is possible that clinical and procedural factors, including aneurysm/vessel characteristics and device manipulation, may have contributed.Herniated coil loops can result in compromise to flow in the vessel or distal thromboembolic complications.Larger coil protrusions that comprise more than half the parent artery diameter or cause hemodynamic alteration require endovascular intervention in addition to antiplatelet therapy.In this case, the stretched coil was left protruding into the parent artery resulting in arterial occlusion and subsequent stroke.Since the reportable alleged failure of coil stretching, premature detachment, and protrusion into parent vessel resulted in arterial occlusion and stroke.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.
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