| Model Number 640CF0620 |
| Device Problem
Premature Separation (4045)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/13/2021 |
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Event Type
Injury
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Event Description
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It was reported by a healthcare professional that a (b)(6) male patient underwent a stent-assisted coil embolization of a right middle cerebral artery (mca) aneurysm.During the procedure, a solitaire ab (medtronic) stent was delivered to the target aneurysm via an echelon 10 microcatheter (medtronic).Next, the physician started to fill the aneurysm with a 6mm x 20cm orbit galaxy tdl complex fill coil (640cf0620, 30478001).After ½ of the coil was in the aneurysm sac, the physician felt the shape of the coil was not ideal.The physician tried to adjust the position of the coil, but the coil prematurely detached.Immediately, the physician used a solitaire ab stent retriever (medtronic) to remove the prematurely detached coil from the patient.The coil was replaced to complete the procedure.There was no report of patient injury.The prematurely detached coil was misplaced and is thus not available for return.It is unknown if the delivery tube and introducer will be returned for evaluation.Additional event information received on 29-nov-2021 indicated that the concomitant devices functioned as expected.Reportedly, there was no issue encountered during positioning of the complaint coil.There was no restriction/reduction of blood flow due to the event.There was an adequate flush maintained through the devices.The surgery was delayed approximately 20 minutes due to the event; the physician did not feel that the prolongation of procedure was clinically significant.No further information could be obtained.The returned medical imaging was reviewed a neurointerventionalist.The assessment reads as follows: ¿the event description provided by the physician indicates premature coil detachment.This event is described in literature and known to occur in = 2% of cases and are not specific to coil type or manufacturer.Typical causes include but are not limited to 1) angulation of the microcatheter, 2) obstructed exit of the microcatheter, 3) inadvertent movement of the microcatheter, 4) device failure.The single image that was supplied shows an aneurysm that is partially filled with coils without significant inflow of contrast.The catheter makes a slightly reversed angle into the aneurysm which potentially can be explained by the stent that was placed.The markers of the stent are not clearly visible, so an exact position is not known.There seems to be a slight change in density in the coil 7 mm proximal to the catheter tip, which can be seen in coils that either are detached or despiralized.Based on the image provided the underlying cause/s for the event cannot be determined with certainty.¿.
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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.(b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: it was reported by a healthcare professional that a (b)(6) male patient underwent a stent-assisted coil embolization of a right middle cerebral artery (mca) aneurysm.During the procedure, a solitaire ab (medtronic) stent was delivered to the target aneurysm via an echelon 10 microcatheter (medtronic).Next, the physician started to fill the aneurysm with a 6mm x 20cm orbit galaxy tdl complex fill coil (640cf0620, 30478001).After ½ of the coil was in the aneurysm sac, the physician felt the shape of the coil was not ideal.The physician tried to adjust the position of the coil, but the coil prematurely detached.Immediately, the physician used a solitaire ab stent retriever (medtronic) to remove the prematurely detached coil from the patient.The coil was replaced to complete the procedure.There was no report of patient injury.The prematurely detached coil was misplaced and is thus not available for return.It is unknown if the delivery tube and introducer will be returned for evaluation.Additional event information received on 29-nov-2021 indicated that the concomitant devices functioned as expected.Reportedly, there was no issue encountered during positioning of the complaint coil.There was no restriction/reduction of blood flow due to the event.There was an adequate flush maintained through the devices.The surgery was delayed approximately 20 minutes due to the event; the physician did not feel that the prolongation of procedure was clinically significant.No further information could be obtained.The returned medical imaging was reviewed a neurointerventionalist.The assessment reads as follows: ¿the event description provided by the physician indicates premature coil detachment.This event is described in literature and known to occur in = 2% of cases and are not specific to coil type or manufacturer.Typical causes include but are not limited to 1) angulation of the microcatheter, 2) obstructed exit of the microcatheter, 3) inadvertent movement of the microcatheter, 4) device failure.The single image that was supplied shows an aneurysm that is partially filled with coils without significant inflow of contrast.The catheter makes a slightly reversed angle into the aneurysm which potentially can be explained by the stent that was placed.The markers of the stent are not clearly visible, so an exact position is not known.There seems to be a slight change in density in the coil 7 mm proximal to the catheter tip, which can be seen in coils that either are detached or despiralized.Based on the image provided the underlying cause/s for the event cannot be determined with certainty.¿ the device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30478001 number, and no non-conformances related to the reported complaint condition were identified.Premature detachment necessitating additional intervention is a known potential complication associated with the use of embolic coils in endovascular embolization.The orbit galaxy instructions for use (ifu) states that appropriate selection of the detachable coil is critical to ensure device effectiveness and patient safety.Examine pre-embolization angiograms in order to choose the optimum device for any given lesion.It is important to select the optimum coil length, coil diameter, and coil type to ensure desired volumetric filling.The ifu further warns that 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.Based on the information provided, it is not possible to determine the root cause of the reported event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting such as aneurysm/vessel characteristics, device selection, device interaction, and operator technique rather than the design or manufacture of the device.The alleged premature coil detachment required additional intervention (i.E., use of a stent retriever) to remove the coil from the patient and preclude patient harm.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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Manufacturer Narrative
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Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion updated with device analysis: it was reported by a healthcare professional that a 59-year-old male patient underwent a stent-assisted coil embolization of a right middle cerebral artery (mca) aneurysm.During the procedure, a solitaire ab (medtronic) stent was delivered to the target aneurysm via an echelon 10 microcatheter (medtronic).Next, the physician started to fill the aneurysm with a 6mm x 20cm orbit galaxy tdl complex fill coil (640cf0620, 30478001).After ½ of the coil was in the aneurysm sac, the physician felt the shape of the coil was not ideal.The physician tried to adjust the position of the coil, but the coil prematurely detached.Immediately, the physician used a solitaire ab stent retriever (medtronic) to remove the prematurely detached coil from the patient.The coil was replaced to complete the procedure.There was no report of patient injury.The prematurely detached coil was misplaced and is thus not available for return.It is unknown if the delivery tube and introducer will be returned for evaluation.Additional event information received on 29-nov-2021 indicated that the concomitant devices functioned as expected.Reportedly, there was no issue encountered during positioning of the complaint coil.There was no restriction/reduction of blood flow due to the event.There was an adequate flush maintained through the devices.The surgery was delayed approximately 20 minutes due to the event; the physician did not feel that the prolongation of procedure was clinically significant.No further information could be obtained.The returned medical imaging was reviewed a neurointerventionalist.The assessment reads as follows: ¿the event description provided by the physician indicates premature coil detachment.This event is described in literature and known to occur in = 2% of cases and are not specific to coil type or manufacturer.Typical causes include but are not limited to 1) angulation of the microcatheter, 2) obstructed exit of the microcatheter, 3) inadvertent movement of the microcatheter, 4) device failure.The single image that was supplied shows an aneurysm that is partially filled with coils without significant inflow of contrast.The catheter makes a slightly reversed angle into the aneurysm which potentially can be explained by the stent that was placed.The markers of the stent are not clearly visible, so an exact position is not known.There seems to be a slight change in density in the coil 7 mm proximal to the catheter tip, which can be seen in coils that either are detached or despiralized.Based on the image provided the underlying cause/s for the event cannot be determined with certainty.¿ a non-sterile og tdl cmplx fill coil 6x20 was received coiled inside of a pouch.The device was inspected, and it was found in good condition.No damages or anomalies were observed during the visual analysis.Residues of dry blood could be noted on the device.The microscopic analysis of the returned sample determined that the coil was already detached from the device, due to this condition the customer complaint ¿coil- premature detachment-during placement¿ was confirmed.However, the exact time when the detachment process occurs could not be conclusively determined.There is no evidence of mechanical detachment or stress that suggests excessive force applied.Premature detachment necessitating additional intervention is a known potential complication associated with the use of embolic coils in endovascular embolization.The orbit galaxy instructions for use (ifu) states that appropriate selection of the detachable coil is critical to ensure device effectiveness and patient safety.Examine pre-embolization angiograms in order to choose the optimum device for any given lesion.It is important to select the optimum coil length, coil diameter, and coil type to ensure desired volumetric filling.The ifu further warns that 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.Based on the information provided, it is not possible to determine the root cause of the reported event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting such as aneurysm/vessel characteristics, device selection, device interaction, and operator technique rather than the design or manufacture of the device.The alleged premature coil detachment required additional intervention (i.E., use of a stent retriever) to remove the coil from the patient and preclude patient harm.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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