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| Model Number 201-D |
| Device Problems
Positioning Failure (1158); Unstable (1667); Separation Failure (2547)
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| Patient Problems
Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
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| Event Date 11/27/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity, were not provided.The name, phone and email address of the initial reporter are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Independent physician review of the complaint description was performed on (b)(6) 2020.The assessment reads as follows: ¿there is no imaging to review.The case is an mca aneurysm that may have been treated in the past based on the terminology ¿multiple case recanalization¿ or it may be an aneurysm in a patient with other treated aneurysms.Regardless, per the report above, the md had difficulty deploying the pulserider in a manner that would permit coiling.The md refers to axial deviation, which i interpret as an angulation in the vessel.This is based on the md¿s description of the events that took place and the knowledge that the mca can often have a severe bend in it.The pulserider may not be able to be deployed in a satisfactory manner when there is a significant bend in the vessel proximal to the aneurysm.In addition, based on the description, the physician appears to really want the leaflets to be extra-aneurysmal in the branching vessels.It is procedurally ok to have a pulserider leaflet in the aneurysm provided that it enables coiling and does not permit occlusion of a branch.Intra-operative dyna ct or cone beam ct with 20% diluted contrast ia injection can delineate the position of a pulserider in-situ.During one of the many re-positionings, it appears the md encountered a vessel perforation.Physician name and date reviewed: (b)(6); (b)(6) 2020.Intracranial hemorrhage, vessel perforation, positioning difficulty, device instability, and failure to detach are known potential procedural complications associated with the pulserider anrd.Since the physician reported that the vessel perforation, which led to cerebral hemorrhage was caused by the pulserider and the event resulted in a serious injury, it meets mdr reporting criteria.Complaint device photo review: based on the photos provided of the complaint device, there were no appearance of damages or abnormalities observed.The pulserider implant remains attached to the delivery wire with the implant component in the deployed state.Further investigation will be performed when the device is returned for evaluation and analysis.A review of manufacturing documentation associated with this lot w3674-13 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Event Description
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The healthcare professional reported that the (b)(6)-year-old female patient who previously has had an lvis stent implanted at the anterior communicating artery (acom) underwent the current procedure targeting an unruptured 2.24mm x 3.02mm (neck 3.71mm) aneurysm at the middle cerebral artery (mca).It was reported that this was a ¿multiple case¿ with recanalization lesion at the acom treated with target® nano¿ coil (stryker).The procedure for targeting the mca aneurysm started and axial deviation was confirmed from the beginning.The pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / w3674-13) was used in accordance with the instructions for use (ifu).The physician introduced the prowler select plus microcatheter (catalog / lot# unknown) and guide catheter with the plan to deploy and implant the pulserider device outside the aneurysm (extra-aneurysmal implantation), however, due to the axial misalignment influence, the pulserider was not implanted.The physician tried to deploy the pulserider implant several times but could not get the leaflets to position into the extra-aneurysmal in the branching vessels.The physician tried by replacing the microcatheter and pointing it toward the superior trunk side, but when the pulserider implant passed, the shape straightened, and the desired effect was not achieved.The physician attempted to deploy the pulserider implant several times, but the leaflet did not fall down on to the superior trunk side.During one of the attempts to re-position the pulserider implant for deployment, the physician encountered a vessel perforation.The hemorrhagic event occurred when the leaflet seemed to have entered the branch that was thought to be the penetrating branch of the mca neck.The procedure was discontinued and treatment for the aneurysm was postponed.The procedure was deemed completed as it was.The patient has been hospitalized.As per the physician, ¿the bleeding is not serious because the bleeding itself did not break the aneurysm.¿ there was no mention of its final severity.Additional information was received indicating that hemostasis was achieved by manual pressure on the carotid artery to induce flow restriction.It was also reported that no additional surgery will be performed.Per the physician, the adverse event is related to the pulserider implant, citing that it was difficult to deploy.¿it took a long time and it is possible that it is also being affected.¿ photos of the complaint device was included by the affiliate.The photos were review by the product analysis team.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by cerenovus product analysis lab on 1218/2018.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that the 56-year-old female patient who previously has had an lvis stent implanted at the anterior communicating artery (acom) underwent the current procedure targeting an unruptured 2.24mm x 3.02mm (neck 3.71mm) aneurysm at the middle cerebral artery (mca).It was reported that this was a ¿multiple case¿ with recanalization lesion at the acom treated with target® nano¿ coil (stryker).The procedure for targeting the mca aneurysm started and axial deviation was confirmed from the beginning.The pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / w3674-13) was used in accordance with the instructions for use (ifu).The physician introduced the prowler select plus microcatheter (catalog / lot# unknown) and guide catheter with the plan to deploy and implant the pulserider device outside the aneurysm (extra-aneurysmal implantation), however, due to the axial misalignment influence, the pulserider was not implanted.The physician tried to deploy the pulserider implant several times but could not get the leaflets to position into the extra-aneurysmal in the branching vessels.The physician tried by replacing the microcatheter and pointing it toward the superior trunk side, but when the pulserider implant passed, the shape straightened, and the desired effect was not achieved.The physician attempted to deploy the pulserider implant several times, but the leaflet did not fall down on to the superior trunk side.During one of the attempts to re-position the pulserider implant for deployment, the physician encountered a vessel perforation.The hemorrhagic event occurred when the leaflet seemed to have entered the branch that was thought to be the penetrating branch of the mca neck.The procedure was discontinued and treatment for the aneurysm was postponed.The procedure was deemed completed as it was.The patient has been hospitalized.As per the physician, ¿the bleeding is not serious because the bleeding itself did not break the aneurysm.¿ there was no mention of its final severity.Additional information was received indicating that hemostasis was achieved by manual pressure on the carotid artery to induce flow restriction.It was also reported that no additional surgery will be performed.Per the physician, the adverse event is related to the pulserider implant, citing that it was difficult to deploy.¿it took a long time and it is possible that it is also being affected.¿ independent physician review of the complaint description was performed on 07 december 2020.The assessment reads as follows: ¿there is no imaging to review.The case is an mca aneurysm that may have been treated in the past based on the terminology ¿multiple case recanalization¿ or it may be an aneurysm in a patient with other treated aneurysms.Regardless, per the report above, the md had difficulty deploying the pulserider in a manner that would permit coiling.The md refers to axial deviation, which i interpret as an angulation in the vessel ¿ this is based on the md¿s description of the events that took place and the knowledge that the mca can often have a severe bend in it.The pulserider may not be able to be deployed in a satisfactory manner when there is a significant bend in the vessel proximal to the aneurysm.In addition, based on the description, the physician appears to really want the leaflets to be extra-aneurysmal in the branching vessels.It is procedurally ok to have a pulserider leaflet in the aneurysm provided that it enables coiling and does not permit occlusion of a branch.Intra-operative dyna ct or cone beam ct with 20% diluted contrast ia injection can delineate the position of a pulserider in-situ.During one of the many re-positionings, it appears the md encountered a vessel perforation.Physician name and date reviewed: (b)(6) md 07 december 2020 photos of the complaint device was included by the affiliate.The photos were review by the product analysis team.Complaint device photo review: based on the photos provided of the complaint device, there were no appearance of damages or abnormalities observed.The pulserider implant remains attached to the delivery wire with the implant component in the deployed state.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device was returned contained in a pouch.Visual inspection was performed.It was noted that the introducer component was not returned with the rest of the device.No damage was observed.Microscopic inspection was performed.The implant was observed to be in good normal condition under magnification.Functional evaluation: a lab sample detachment controller was prepared for detachment.The lab sample pulserider accessory cable was connected to the controller.The black cable was then connected to a suitable conductive electrode immersed in a saline solution and the red cable was connected to the proximal end of the pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device anrd and immersed in the saline solution.The detachment button was pressed to initiate the detachment cycle.The green light flashed and displayed that the implant was detached.A review of manufacturing documentation associated with this lot w3674-13 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Positioning difficulty / inability to position, device instability prior to detachment are known potential issues associated with the use of the device.Factors such as the shape of the target lesion and the tortuosity of the parent vessel may be contributing factors to the way the device is positioned and its stability in the placement prior to detachment.Per the pulserider instructions for use (ifu): when the implant is in position and deployed at the desired location, ensure the microcatheter has been sufficiently retracted to allow the implant to unsheathe fully.Verify the implant is fully deployed by confirming that the delivery wire marker is distal to the microcatheter tip marker.Place the coil delivery microcatheter through the pulserider implant and into the sac of the aneurysm.Proceed carefully with coiling the aneurysm.The pulserider implant should remain attached to the delivery wire until a sufficient basket of coils has been placed within the aneurysm to prevent the pulserider implant from being unintentionally advanced into the aneurysmal sac.Use fluoroscopy to confirm that the implant has remained in the desired position and that the delivery wire marker is distal to the microcatheter tip (this ensures that the predetermined delivery wire detachment zone is exposed and ready for detachment).The physician reportedly attempted to detach the anrd without exposing the predetermined delivery wire detachment zone from the concomitant microcatheter.Positioning issue and the stability of the device also is procedurally dependent on the patient¿s anatomy.The patient in this case also had a previously implanted stent, as stated, the procedure is a ¿multiple case recanalization¿ with confirmed axial deviation.Based on the review of manufacturing documentation, there is no indication that the event is related to the device manufacturing process.Root case of the reported issues remain speculative and inconclusive.The failure to detach issue was not confirmed based on the functional evaluation performed.The returned pulserider device underwent functional evaluation with the returned concomitant pulserider accessory cable.The implant detached without any issue.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report a correction to the imdrf health impact code and the medical device problem code associated with the reported event related to the pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device (anrd).The event underwent a re-review on 20 may 2021, and the correction of the codes to better reflect the reported event was the result of this review.[conclusion]: the healthcare professional reported that the 56-year-old female patient who previously has had an lvis stent implanted at the anterior communicating artery (acom) underwent the current procedure targeting an unruptured 2.24mm x 3.02mm (neck 3.71mm) aneurysm at the middle cerebral artery (mca).It was reported that this was a ¿multiple case¿ with recanalization lesion at the acom treated with target® nano¿ coil (stryker).The procedure for targeting the mca aneurysm started and axial deviation was confirmed from the beginning.The pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / w3674-13) was used in accordance with the instructions for use (ifu).The physician introduced the prowler select plus microcatheter (catalog / lot# unknown) and guide catheter with the plan to deploy and implant the pulserider device outside the aneurysm (extra-aneurysmal implantation), however, due to the axial misalignment influence, the pulserider was not implanted.The physician tried to deploy the pulserider implant several times but could not get the leaflets to position into the extra-aneurysmal in the branching vessels.The physician tried by replacing the microcatheter and pointing it toward the superior trunk side, but when the pulserider implant passed, the shape straightened, and the desired effect was not achieved.The physician attempted to deploy the pulserider implant several times, but the leaflet did not fall down on to the superior trunk side.During one of the attempts to re-position the pulserider implant for deployment, the physician encountered a vessel perforation.The hemorrhagic event occurred when the leaflet seemed to have entered the branch that was thought to be the penetrating branch of the mca neck.The procedure was discontinued and treatment for the aneurysm was postponed.The procedure was deemed completed as it was.The patient has been hospitalized.As per the physician, ¿the bleeding is not serious because the bleeding itself did not break the aneurysm.¿ there was no mention of its final severity.Additional information was received indicating that hemostasis was achieved by manual pressure on the carotid artery to induce flow restriction.It was also reported that no additional surgery will be performed.Per the physician, the adverse event is related to the pulserider implant, citing that it was difficult to deploy.¿it took a long time and it is possible that it is also being affected.¿.Independent physician review of the complaint description was performed on 07 december 2020.The assessment reads as follows: ¿there is no imaging to review.The case is an mca aneurysm that may have been treated in the past based on the terminology ¿multiple case recanalization¿ or it may be an aneurysm in a patient with other treated aneurysms.Regardless, per the report above, the md had difficulty deploying the pulserider in a manner that would permit coiling.The md refers to axial deviation, which i interpret as an angulation in the vessel ¿ this is based on the md¿s description of the events that took place and the knowledge that the mca can often have a severe bend in it.The pulserider may not be able to be deployed in a satisfactory manner when there is a significant bend in the vessel proximal to the aneurysm.In addition, based on the description, the physician appears to really want the leaflets to be extra-aneurysmal in the branching vessels.It is procedurally ok to have a pulserider leaflet in the aneurysm provided that it enables coiling and does not permit occlusion of a branch.Intra-operative dyna ct or cone beam ct with 20% diluted contrast ia injection can delineate the position of a pulserider in-situ.During one of the many re-positionings, it appears the md encountered a vessel perforation.Physician name and date reviewed: (b)(6) md / 07 december 2020.Photos of the complaint device was included by the affiliate.The photos were review by the product analysis team.Complaint device photo review: based on the photos provided of the complaint device, there were no appearance of damages or abnormalities observed.The pulserider implant remains attached to the delivery wire with the implant component in the deployed state.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device was returned contained in a pouch.Visual inspection was performed.It was noted that the introducer component was not returned with the rest of the device.No damage was observed.Microscopic inspection was performed.The implant was observed to be in good normal condition under magnification.Functional evaluation: a lab sample detachment controller was prepared for detachment.The lab sample pulserider accessory cable was connected to the controller.The black cable was then connected to a suitable conductive electrode immersed in a saline solution and the red cable was connected to the proximal end of the pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device anrd and immersed in the saline solution.The detachment button was pressed to initiate the detachment cycle.The green light flashed and displayed that the implant was detached.A review of manufacturing documentation associated with this lot w3674-13 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Positioning difficulty / inability to position is a known potential issue associated with the use of the device.Factors such as the shape of the target lesion and the tortuosity of the parent vessel may be contributing factors to the way the device is positioned.Per the pulserider instructions for use (ifu): when the implant is in position and deployed at the desired location, ensure the microcatheter has been sufficiently retracted to allow the implant to unsheathe fully.Verify the implant is fully deployed by confirming that the delivery wire marker is distal to the microcatheter tip marker.Place the coil delivery microcatheter through the pulserider implant and into the sac of the aneurysm.Proceed carefully with coiling the aneurysm.The pulserider implant should remain attached to the delivery wire until a sufficient basket of coils has been placed within the aneurysm to prevent the pulserider implant from being unintentionally advanced into the aneurysmal sac.Use fluoroscopy to confirm that the implant has remained in the desired position and that the delivery wire marker is distal to the microcatheter tip (this ensures that the predetermined delivery wire detachment zone is exposed and ready for detachment).The physician reportedly attempted to detach the anrd without exposing the predetermined delivery wire detachment zone from the concomitant microcatheter.Positioning issue is also procedurally dependent on the patient¿s anatomy.The patient in this case also had a previously implanted stent, as stated, the procedure is a ¿multiple case recanalization¿ with confirmed axial deviation.Based on the review of manufacturing documentation, there is no indication that the event is related to the device manufacturing process.Root case of the reported issues remain speculative and inconclusive.Positioning difficulty and intracranial hemorrhage secondary to vessel perforation are known potential procedural complications associated with the pulserider anrd.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.Since the physician reported that the vessel perforation which led to cerebral hemorrhage was caused by the pulserider device, the event meets mdr reporting criteria with the classification of "serious injury.".As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.H.11: corrected data: the health effect impact codes of 'change in therapeutic response (f01)' and inadequate / inappropriate treatment or diagnostic exposure (f10)' were added.The initially reported medical device problem code: ¿unstable (a051207)¿ and ¿separation failure (a150301)¿ were removed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.The health effect impact codes of 'change in therapeutic response (f01)' and 'inadequate/inappropriate treatment or diagnostic exposure (f10)' were added.The initially reported medical device problem code: ¿unstable (a051207)¿ and ¿separation failure (a150301)¿ were removed.
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Search Alerts/Recalls
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