Catalog Number UNK_NEU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Aneurysm (1708); Death (1802); Intracranial Hemorrhage (1891); Thrombosis (2100); Perforation of Vessels (2135); Rupture (2208); Device Embedded In Tissue or Plaque (3165)
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Event Date 10/14/2019 |
Event Type
Death
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Manufacturer Narrative
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The subject device is unavailable to manufacturer.
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Event Description
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The patient underwent stenting of a complex, incidental aneurysm basilar artery (ba).The aneurysm was located at the base of a ba fenestration.The treatment plan was to deliver a subject device fd (flow diverter) from the right vertebral arteries (va) into the ipsilateral branch of the ba fenestration.In a second step the plan was to position a stent from the left va into the ipsilateral branch of the ba fenestration with a microcatheter jailed within the aneurysm.The patient was under dual antiplatelet therapy (dat) with acetylsalicylic acid aspirin (ass) and clopidogrel, multiple of tests from the same day confirmed that the patient was responding to dat.In addition, 5000 i.U.Heparin were administered iv (intravenous) at the start of the procedure.The subject device fd was positioned without any difficulties with very good flow at the control digital subtraction angiography (dsa) after subject device fd placement.In addition, very good wall apposition and no signs of fish-mouthing.Swift placement of the acclino stent at the contralateral va and subsequent coiling of the aneurysm.On 2 control dsa¿s during coiling the left va as well as the acclino stent remained patent.On the third control dsa after approx.18 coils, occlusion of the acclino stent.Catheterization of the right va.Dsa revealed occlusion of the subject device fd.Angiograms via both ica¿s displayed only sparse collateral flow via the pcom (posterior communicating artery) arteries.Again, catheterization of the right va.Angiograms in the working projection exhibited no signs of mechanical obstruction of the subject device fd.A microcatheter could be delivered through the occluded subject device subject device fd into the ba.A dsa run presented mild reconstitution of flow through the subject device fd.Catheters were removed from the right va.Administration of tirofiban iv (aggrastat).Angiographic controls via the right va 20 minutes after iv tirofiban showed re-occlusion of the subject device fd.The distal end of the subject device fd stent appeared narrowed.The subject device fd stent was then ballooned with a hyper-compliant, low-pressure balloon.During this maneuver the branch of the ba fenestration outside the subject device fd stent ruptured.The anesthesia had to be prolonged and the unknown item remained inside the patient.No other information was provided.
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Manufacturer Narrative
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Outcomes attributed to ae - updated to death.Type of reportable event - updated to death.Executive summary- updated: received additional information on 22-november-2019 stated that the patient passed away.The date and the cause of the patient's death are unknown.No other information was provided.Corrected - product long description: unknown (surpass streamline).The neurovascular stryker surpass evolve device is not currently not approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).
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Event Description
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The patient underwent stenting of a complex, incidental aneurysm basilar artery (ba).The aneurysm was located at the base of a ba fenestration.The treatment plan was to deliver a subject device fd (flow diverter) from the right vertebral arteries (va) into the ipsilateral branch of the ba fenestration.In a second step the plan was to position a stent from the left va into the ipsilateral branch of the ba fenestration with a microcatheter jailed within the aneurysm.The patient was under dual antiplatelet therapy (dat) with acetylsalicylic acid aspirin (ass) and clopidogrel, multiple of tests from the same day confirmed that the patient was responding to dat.In addition, 5000 i.U.Heparin were administered iv (intravenous) at the start of the procedure.The subject device fd was positioned without any difficulties with very good flow at the control digital subtraction angiography (dsa) after subject device fd placement.In addition, very good wall apposition and no signs of fish-mouthing.Swift placement of the acclino stent at the contralateral va and subsequent coiling of the aneurysm.On 2 control dsa¿s during coiling the left va as well as the acclino stent remained patent.On the third control dsa after approx.18 coils, occlusion of the acclino stent.Catheterization of the right va.Dsa revealed occlusion of the subject device fd.Angiograms via both ica¿s displayed only sparse collateral flow via the pcom (posterior communicating artery) arteries.Again, catheterization of the right va.Angiograms in the working projection exhibited no signs of mechanical obstruction of the subject device fd.A microcatheter could be delivered through the occluded subject device subject device fd into the ba.A dsa run presented mild reconstitution of flow through the subject device fd.Catheters were removed from the right va.Administration of tirofiban iv (aggrastat).Angiographic controls via the right va 20 minutes after iv tirofiban showed re- occlusion of the subject device fd.The distal end of the subject device fd stent appeared narrowed.The subject device fd stent was then ballooned with a hyper-compliant, low- pressure balloon.During this maneuver the branch of the ba fenestration outside the subject device fd stent ruptured.The anesthesia had to be prolonged and the unknown item remained inside the patient.No other information was provided.Update information: received additional information on 22-november-2019 stated that the patient passed away.The date and the cause of the patient's death are unknown.No other information was provided.
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Manufacturer Narrative
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Expiration date - added.Manufacturing date ¿ added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It cannot be determined from the available information whether the unreprieved device fragments caused the reported event.As the device was not returned for analysis and the available information fails to indicate a caused for the device fracture, therefore an assignable cause of undeterminable will be assigned to the reported "unretrieved device fragments".An assignable cause of "anticipated procedural complication" will be assigned to the reported "patient vessel thrombosis, patient vessel perforation and patient death", as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
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Event Description
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The patient underwent stenting of a complex, incidental aneurysm basilar artery (ba).The aneurysm was located at the base of a ba fenestration.The treatment plan was to deliver a subject device fd (flow diverter) from the right vertebral arteries (va) into the ipsilateral branch of the ba fenestration.In a second step the plan was to position a stent from the left va into the ipsilateral branch of the ba fenestration with a microcatheter jailed within the aneurysm.The patient was under dual antiplatelet therapy (dat) with acetylsalicylic acid aspirin (ass) and clopidogrel, multiple of tests from the same day confirmed that the patient was responding to dat.In addition, 5000 i.U.Heparin were administered iv (intravenous) at the start of the procedure.The subject device fd was positioned without any difficulties with very good flow at the control digital subtraction angiography (dsa) after subject device fd placement.In addition, very good wall apposition and no signs of fish-mouthing.Swift placement of the acclino stent at the contralateral va and subsequent coiling of the aneurysm.On 2 control dsa¿s during coiling the left va as well as the acclino stent remained patent.On the third control dsa after approx.18 coils, occlusion of the acclino stent.Catheterization of the right va.Dsa revealed occlusion of the subject device fd.Angiogramms via both ica¿s displayed only sparse collateral flow via the pcom (posterior communicating artery) arteries.Again, catheterization of the right va.Angiogramms in the working projection exhibited no signs of mechanical obstruction of the subject device fd.A microcatheter could be delivered through the occludeds subject device subject device fd into the ba.A dsa run presented mild reconstitution of flow through the subject device fd.Catheters were removed from the right va.Administration of tirofiban iv (aggrastat).Angiographic controls via the right va 20 minutes after iv tirofiban showed re- occlusion of the subject device fd.The distal end of the subject device fd stent appeared narrowed.The subject device fd stent was then ballooned with a hyper-compliant, low- pressure balloon.During this maneuver the branch of the ba fenestration outside the subject device fd stent ruptured.The anesthesia had to be prolonged and the unknown item remained inside the patient.No other information was provided.Update information: received additional information on (b)(6) 2019 stated that the patient passed away.The date and the cause of the patient's death are unknown.No other information was provided.
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Event Description
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The patient underwent stenting of a complex, incidental aneurysm basilar artery (ba).The aneurysm was located at the base of a ba fenestration.The treatment plan was to deliver a subject device fd (flow diverter) from the right vertebral arteries (va) into the ipsilateral branch of the ba fenestration.In a second step the plan was to position a stent from the left va into the ipsilateral branch of the ba fenestration with a microcatheter jailed within the aneurysm.The patient was under dual antiplatelet therapy (dat) with acetylsalicylic acid aspirin (ass) and clopidogrel, multiple of tests from the same day confirmed that the patient was responding to dat.In addition, 5000 i.U.Heparin were administered iv (intravenous) at the start of the procedure.The subject device fd was positioned without any difficulties with very good flow at the control digital subtraction angiography (dsa) after subject device fd placement.In addition, very good wall apposition and no signs of fish-mouthing.Swift placement of the acclino stent at the contralateral va and subsequent coiling of the aneurysm.On 2 control dsa¿s during coiling the left va as well as the acclino stent remained patent.On the third control dsa after approx.18 coils, occlusion of the acclino stent.Catheterization of the right va.Dsa revealed occlusion of the subject device fd.Angiograms via both ica¿s displayed only sparse collateral flow via the pcom (posterior communicating artery) arteries.Again, catheterization of the right va.Angiograms in the working projection exhibited no signs of mechanical obstruction of the subject device fd.A microcatheter could be delivered through the occluded subject device subject device fd into the ba.A dsa run presented mild reconstitution of flow through the subject device fd.Catheters were removed from the right va.Administration of tirofiban iv (aggrastat).Angiographic controls via the right va 20 minutes after iv tirofiban showed re- occlusion of the subject device fd.The distal end of the subject device fd stent appeared narrowed.The subject device fd stent was then ballooned with a hyper-compliant, low- pressure balloon.During this maneuver the branch of the ba fenestration outside the subject device fd stent ruptured.The anesthesia had to be prolonged and the unknown item remained inside the patient.No other information was provided.Update information: received additional information on 22-november-2019 stated that the patient passed away.The date and the cause of the patient's death are unknown.No other information was provided.Second update information.Received additional information on 18-december -2019 stated that the patient's death was caused by the brain death as a result of subarachnoid hemorrhage and occlusion of the basilar artery with damage to the brain stem on both sides.There is a causal connection between the intervention with the subject device fd (flow diverter) and the death of the patient view.After insertion of the subject device fd (flow diverter), an in-stent thrombosis with occlusion of the subject device fd (flow diverter) stents.When attempting to reopen the stent, one leg of the fenestration of the basilar artery was ruptured subsequent subarachnoid hemorrhage.In addition, the subject device fd (flow diverter) and the a basilar is remained closed.The infarcts in the areas of the brainstem that resulted from this eventually led to the patient's death.The subject device fd (flow diverter) remained implanted.
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Manufacturer Narrative
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Updated information: received additional information on 18-december -2019 stated that the patient's death was caused by the brain death as a result of subarachnoid hemorrhage and occlusion of the basilar artery with damage to the brain stem on both sides.There is a causal connection between the intervention with the subject device fd (flow diverter) and the death of the patient view.After insertion of the subject device fd (flow diverter), an in-stent thrombosis with occlusion of the subject device fd (flow diverter) stents.When attempting to reopen the stent, one leg of the fenestration of the basilar artery was ruptured subsequent subarachnoid hemorrhage.In addition, the subject device fd (flow diverter) and the a basilar is remained closed.The infarcts in the areas of the brainstem that resulted from this eventually led to the patient's death.The subject device fd (flow diverter) remained implanted.Updated - the subject device remained inside patient.Patient code grid - updated : removed "un-retrieved device fragment" and added "intracranial hemorrhage.".
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Manufacturer Narrative
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The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of anticipated procedural complication will be assigned to the reported "patient vessel thrombosis, patient vessel perforation, patient intercranial hemorrhage and patient death", as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
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Event Description
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The patient underwent stenting of a complex, incidental aneurysm basilar artery (ba).The aneurysm was located at the base of a ba fenestration.The treatment plan was to deliver a subject device fd (flow diverter) from the right vertebral arteries (va) into the ipsilateral branch of the ba fenestration.In a second step the plan was to position a stent from the left va into the ipsilateral branch of the ba fenestration with a microcatheter jailed within the aneurysm.The patient was under dual antiplatelet therapy (dat) with acetylsalicylic acid aspirin (ass) and clopidogrel, multiple of tests from the same day confirmed that the patient was responding to dat.In addition, 5000 i.U.Heparin were administered iv (intravenous) at the start of the procedure.The subject device fd was positioned without any difficulties with very good flow at the control digital subtraction angiography (dsa) after subject device fd placement.In addition, very good wall apposition and no signs of fish-mouthing.Swift placement of the acclino stent at the contralateral va and subsequent coiling of the aneurysm.On 2 control dsa¿s during coiling the left va as well as the acclino stent remained patent.On the third control dsa after approx.18 coils, occlusion of the acclino stent.Catheterization of the right va.Dsa revealed occlusion of the subject device fd.Angiograms via both ica¿s displayed only sparse collateral flow via the pcom (posterior communicating artery) arteries.Again, catheterization of the right va.Angiograms in the working projection exhibited no signs of mechanical obstruction of the subject device fd.A microcatheter could be delivered through the occluded s subject device subject device fd into the ba.A dsa run presented mild reconstitution of flow through the subject device fd.Catheters were removed from the right va.Administration of tirofiban iv (aggrastat).Angiographic controls via the right va 20 minutes after iv tirofiban showed re- occlusion of the subject device fd.The distal end of the subject device fd stent appeared narrowed.The subject device fd stent was then ballooned with a hyper-compliant, low- pressure balloon.During this maneuver the branch of the ba fenestration outside the subject device fd stent ruptured.The anesthesia had to be prolonged and the unknown item remained inside the patient.No other information was provided.Update information: received additional information on 22-november 2019 stated that the patient passed away.The date and the cause of the patient's death are unknown.No other information was provided.Second update information.Received additional information on 18-december 2019 stated that the patient's death was caused by the brain death as a result of subarachnoid hemorrhage and occlusion of the basilar artery with damage to the brain stem on both sides.There is a causal connection between the intervention with the subject device fd (flow diverter) and the death of the patient view.After insertion of the subject device fd (flow diverter), an in-stent thrombosis with occlusion of the subject device fd (flow diverter) stents.When attempting to reopen the stent, one leg of the fenestration of the basilar artery was ruptured subsequent subarachnoid hemorrhage.In addition, the subject device fd (flow diverter) and the a basilar is remained closed.The infarcts in the areas of the brainstem that resulted from this eventually led to the patient's death.The subject device fd (flow diverter) remained implanted.
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Search Alerts/Recalls
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