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MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT
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| Model Number 211-D |
| Device Problems
Malposition of Device (2616); Difficult or Delayed Separation (4044)
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| Patient Problems
Aneurysm (1708); Intracranial Hemorrhage (1891)
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| Event Date 06/29/2021 |
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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 identifier, date of birth, age, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that a male patient underwent a pulserider-assisted coil embolization of a basilar artery aneurysm and experienced intraoperative aneurysm rupture.The pulserider t 10mm arch, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / 3051697708) was deployed at the target aneurysm, and coil embolization was started.A 5mm x 15cm galaxy g3 coil was used to frame the aneurysm and two galaxy g3 xsft (4mm x 10cm & 4mm x 6cm) were used as filling coils.A 3mm x 4cm galaxy g3 mini (glm930040 / l13708) was allegedly used as per the instructions for use (ifu) as the fourth coil, but bleeding was confirmed from a bleb above the aneurysm.A total of nine galaxy g3 mini coils were subsequently implanted for hemostasis.Angiography showed no further bleeding from the bleb.After coiling was completed, the physician attempted to detach the pulserider anrd implant, but the ancillary detachment controller (product code & lot number unknown) displayed an error.The physician made three attempts to detach the device, but a flashing red light displayed on the controller.The pulserider accessory cable (prdsacd / 30393940) was replaced, but the same issue continued.The concomitant prowler select plus microcatheter was delivered to check detachment and it was verified that the implant had detached.The procedure was completed.It was reported that the patient has been recovering gradually in the intensive care unit (icu).The physician commented that the rupture was not serious because bleeding was ¿a little¿ and it resolved with coil embolization.He judged that there would be no problem if post-operative management was performed.Additional treatment will not be provided.The physician further stated that the rupture was related to the complaint coil.Since the tip of the concomitant catheter (brand not specified) was located in the center of the aneurysm, the complaint coil went into the bleb leading to the rupture.On 09 july 2021, additional information was received.The information indicated that during the index procedure, the tip was inserted and implanted at the protrusion (incomplete expansion) between the left posterior cerebral artery and the left superior cerebellar artery.At that time, the physician judged that it was not in the aneurysm.He also judged that the leaflet of the pulserider covered the aneurysm neck, so coil embolization was performed, and the procedure was completed.On the evening of (b)(6) 2021, nine days following the index procedure, the nurse found that the patient had a decreased level of consciousness and dilated pupils, so a computed tomography (ct) and an angiographic examination were urgently performed.The examination revealed that the pulserider passed through the prominence and protruded out of the aneurysm.Bleeding was also observed, parent vessel occlusion was also considered but it was confirmed via angiography that the bleeding had stopped.Thus, no special treatment was given for the time being and the patient was admitted to the icu to receive general anesthesia and antihypertensive management.Hematoma developed at the bleeding site which required ventricular drainage in the operating room.The physician considered that the pressure of the left leaflet on the vessel wall (aneurysm wall) caused the complaint device to protrude out of the blood vessel because of incomplete implantation.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3051697708) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Aneurysm perforation is a known potential adverse event associated with coil embolization procedures.Manipulation of devices in or near the intracranial aneurysm increases the risk of rupturing the fragile aneurysm wall.With the amount of information available and without procedural films, it is not possible to draw a clinical conclusion between the devices and two instances of aneurysm perforation.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device manipulation, device interaction, device selection, and operator technique that may have contributed rather than the design or manufacture of the devices.Based on the information provided, there may have been sudden movement of the microcatheter tip and coil during coil implantation which may have caused the intraoperative aneurysm perforation.Since aneurysm perforation is considered a serious injury and the relationship of the devices to the aneurysm perforation cannot be clearly established, the event meets mdr reporting criteria for both devices.Difficulty to detach is a known potential product failure associated with the use of the pulserider anrd system.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the event.However, the detachment difficulty may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the devices.It is not clear whether the detachment cycle light or the battery charge indicator was noted to be flashing on attempt to detach the pulserider.If the battery indicator is flashing red, then the battery is low.If the battery charge indicator starts flashing in red, the detachment process currently in progress can still be carried out to completion.If the detachment cycle light was flashing, then there would have been a steady audible sound as well meaning the connections were not complete.There is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended, however the potential that it could cause or contribute to a death or serious injury, or another significant adverse event is remote.Thus, the detachment difficulty does not meet mdr reporting criteria.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 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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00279.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 a male patient underwent a pulserider-assisted coil embolization of a basilar artery aneurysm and experienced intraoperative aneurysm rupture.The pulserider t 10mm arch, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / 3051697708) was deployed at the target aneurysm, and coil embolization was started.A 5mm x 15cm galaxy g3 coil was used to frame the aneurysm and two galaxy g3 xsft (4mm x 10cm & 4mm x 6cm) were used as filling coils.A 3mm x 4cm galaxy g3 mini (glm930040 / l13708) was allegedly used as per the instructions for use (ifu) as the fourth coil, but bleeding was confirmed from a bleb above the aneurysm.A total of nine galaxy g3 mini coils were subsequently implanted for hemostasis.Angiography showed no further bleeding from the bleb.After coiling was completed, the physician attempted to detach the pulserider anrd implant, but the ancillary detachment controller (product code & lot number unknown) displayed an error.The physician made three attempts to detach the device, but a flashing red light displayed on the controller.The pulserider accessory cable (prdsacd / 30393940) was replaced, but the same issue continued.The concomitant prowler select plus microcatheter was delivered to check detachment and it was verified that the implant had detached.The procedure was completed.It was reported that the patient has been recovering gradually in the intensive care unit (icu).The physician commented that the rupture was not serious because bleeding was ¿a little¿ and it resolved with coil embolization.He judged that there would be no problem if post-operative management was performed.Additional treatment will not be provided.The physician further stated that the rupture was related to the complaint coil.Since the tip of the concomitant catheter (brand not specified) was located in the center of the aneurysm, the complaint coil went into the bleb leading to the rupture.On 09 july 2021, additional information was received.The information indicated that during the index procedure, the tip was inserted and implanted at the protrusion (incomplete expansion) between the left posterior cerebral artery and the left superior cerebellar artery.At that time, the physician judged that it was not in the aneurysm.He also judged that the leaflet of the pulserider covered the aneurysm neck, so coil embolization was performed, and the procedure was completed.On the evening of (b)(6) 2021, nine days following the index procedure, the nurse found that the patient had a decreased level of consciousness and dilated pupils, so a computed tomography (ct) and an angiographic examination were urgently performed.The examination revealed that the pulserider passed through the prominence and protruded out of the aneurysm.Bleeding was also observed, parent vessel occlusion was also considered but it was confirmed via angiography that the bleeding had stopped.Thus, no special treatment was given for the time being and the patient was admitted to the icu to receive general anesthesia and antihypertensive management.Hematoma developed at the bleeding site which required ventricular drainage in the operating room.The physician considered that the pressure of the left leaflet on the vessel wall (aneurysm wall) caused the complaint device to protrude out of the blood vessel because of incomplete implantation.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on (b)(6) 2021.[additional information]: the healthcare professional reported that a male patient underwent a pulserider-assisted coil embolization of a basilar artery aneurysm and experienced intraoperative aneurysm rupture.The pulserider t 10mm arch, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / (b)(6)) was deployed at the target aneurysm, and coil embolization was started.A 5mm x 15cm galaxy g3 coil was used to frame the aneurysm and two galaxy g3 xsft (4mm x 10cm & 4mm x 6cm) were used as filling coils.A 3mm x 4cm galaxy g3 mini ((b)(6) / (b)(6)) was allegedly used as per the instructions for use (ifu) as the fourth coil, but bleeding was confirmed from a bleb above the aneurysm.A total of nine galaxy g3 mini coils were subsequently implanted for hemostasis.Angiography showed no further bleeding from the bleb.After coiling was completed, the physician attempted to detach the pulserider anrd implant, but the ancillary detachment controller (product code & lot number unknown) displayed an error.The physician made three attempts to detach the device, but a flashing red light displayed on the controller.The pulserider accessory cable (prdsacd / 30393940) was replaced, but the same issue continued.The concomitant prowler select plus microcatheter was delivered to check detachment and it was verified that the implant had detached.The procedure was completed.It was reported that the patient has been recovering gradually in the intensive care unit (icu).The physician commented that the rupture was not serious because bleeding was ¿a little¿ and it resolved with coil embolization.He judged that there would be no problem if post-operative management was performed.Additional treatment will not be provided.The physician further stated that the rupture was related to the complaint coil.Since the tip of the concomitant catheter (brand not specified) was located in the center of the aneurysm, the complaint coil went into the bleb leading to the rupture.On (b)(6) 2021, additional information was received.The information indicated that during the index procedure, the tip was inserted and implanted at the protrusion (incomplete expansion) between the left posterior cerebral artery and the left superior cerebellar artery.At that time, the physician judged that it was not in the aneurysm.He also judged that the leaflet of the pulserider covered the aneurysm neck, so coil embolization was performed, and the procedure was completed.On the evening of thursday, (b)(6) 2021, nine days following the index procedure, the nurse found that the patient had a decreased level of consciousness and dilated pupils, so a computed tomography (ct) and an angiographic examination were urgently performed.The examination revealed that the pulserider passed through the prominence and protruded out of the aneurysm.Bleeding was also observed, parent vessel occlusion was also considered but it was confirmed via angiography that the bleeding had stopped.Thus, no special treatment was given for the time being and the patient was admitted to the icu to receive general anesthesia and antihypertensive management.Hematoma developed at the bleeding site which required ventricular drainage in the operating room.The physician considered that the pressure of the left leaflet on the vessel wall (aneurysm wall) caused the complaint device to protrude out of the blood vessel because of incomplete implantation.On (b)(6) 2021, additional information was received.The information indicated that there are two pulserider anrds available in the t formation (8t and 10t).In this case, the larger one was used (10t).However, the physician commented that the smaller size (8t) may have been a better choice because the aneurysm neck size was 8mm or less.The physician initially selected an 8t device.However, during preoperative 3d simulation, the neck coverage provided by the 8t device was considered insufficient.The 10t was also tested.The physician determined that the neck coverage was better than the 8t device and as a result, the 10t pulserider anrd was selected for use during the procedure.The vessel diameter of the pca was ¿not so thick¿; even if the physician tried to expand the 10t, the leaflets did not enter on both sides well, resulting in a y-shape expansion.The physician commented that since there is a 2mm difference in arch width between the 8t and 10t, ¿if 8t was used, the arch might have successfully entered the pca.¿ the adverse event reported was a case of postoperative perforation of the arch, which was incompletely deployed near the right pca.The physician considered there was no safety issue during the procedure.The physician was also aware of the incomplete expansion, however, the radial force of the leaflets (the force it takes to return to the original form) was not so high; therefore, the procedure was completed with this development.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00279 and 3008114965-2021-00330.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 include the additional event information received on (b)(6) and (b)(6) 2021.E.1: initial reporter phone: (b)(6).[additional information]: the healthcare professional reported that a male patient underwent a pulserider-assisted coil embolization of a basilar artery aneurysm and experienced intraoperative aneurysm rupture.The pulserider t 10mm arch, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / 3051697708) was deployed at the target aneurysm, and coil embolization was started.A 5mm x 15cm galaxy g3 coil was used to frame the aneurysm and two galaxy g3 xsft (4mm x 10cm & 4mm x 6cm) were used as filling coils.A 3mm x 4cm galaxy g3 mini (glm930040 / l13708) was allegedly used as per the instructions for use (ifu) as the fourth coil, but bleeding was confirmed from a bleb above the aneurysm.A total of nine galaxy g3 mini coils were subsequently implanted for hemostasis.Angiography showed no further bleeding from the bleb.After coiling was completed, the physician attempted to detach the pulserider anrd implant, but the ancillary detachment controller (product code & lot number unknown) displayed an error.The physician made three attempts to detach the device, but a flashing red light displayed on the controller.The pulserider accessory cable (prdsacd / 30393940) was replaced, but the same issue continued.The concomitant prowler select plus microcatheter was delivered to check detachment and it was verified that the implant had detached.The procedure was completed.It was reported that the patient has been recovering gradually in the intensive care unit (icu).The physician commented that the rupture was not serious because bleeding was ¿a little¿ and it resolved with coil embolization.He judged that there would be no problem if post-operative management was performed.Additional treatment will not be provided.The physician further stated that the rupture was related to the complaint coil.Since the tip of the concomitant catheter (brand not specified) was located in the center of the aneurysm, the complaint coil went into the bleb leading to the rupture.On (b)(6) 2021, additional information was received.The information indicated that during the index procedure, the tip was inserted and implanted at the protrusion (incomplete expansion) between the left posterior cerebral artery and the left superior cerebellar artery.At that time, the physician judged that it was not in the aneurysm.He also judged that the leaflet of the pulserider covered the aneurysm neck, so coil embolization was performed, and the procedure was completed.On the evening of thursday, (b)(6) 2021, nine days following the index procedure, the nurse found that the patient had a decreased level of consciousness and dilated pupils, so a computed tomography (ct) and an angiographic examination were urgently performed.The examination revealed that the pulserider passed through the prominence and protruded out of the aneurysm.Bleeding was also observed, parent vessel occlusion was also considered but it was confirmed via angiography that the bleeding had stopped.Thus, no special treatment was given for the time being and the patient was admitted to the icu to receive general anesthesia and antihypertensive management.Hematoma developed at the bleeding site which required ventricular drainage in the operating room.The physician considered that the pressure of the left leaflet on the vessel wall (aneurysm wall) caused the complaint device to protrude out of the blood vessel because of incomplete implantation.On (b)(6) 2021, additional information was received.The information indicated that there are two pulserider anrds available in the t formation (8t and 10t).In this case, the larger one was used (10t).However, the physician commented that the smaller size (8t) may have been a better choice because the aneurysm neck size was 8mm or less.The physician initially selected an 8t device.However, during preoperative 3d simulation, the neck coverage provided by the 8t device was considered insufficient.The 10t was also tested.The physician determined that the neck coverage was better than the 8t device and as a result, the 10t pulserider anrd was selected for use during the procedure.The vessel diameter of the pca was ¿not so thick¿; even if the physician tried to expand the 10t, the leaflets did not enter on both sides well, resulting in a y-shape expansion.The physician commented that since there is a 2mm difference in arch width between the 8t and 10t, ¿if 8t was used, the arch might have successfully entered the pca.¿ the adverse event reported was a case of postoperative perforation of the arch, which was incompletely deployed near the right pca.The physician considered there was no safety issue during the procedure.The physician was also aware of the incomplete expansion, however, the radial force of the leaflets (the force it takes to return to the original form) was not so high; therefore, the procedure was completed with this development.Additional information was received on (b)(6) 2021 indicating that anonymized images / angiographs of the procedure will be provided if they are made available.It is not known if the patient has received; he has been hospitalized as described in the event description.On (b)(6) 2021, clarification was received from the local quality team that the prowler select plus (unknown product code & lot number) was the only microcatheter used for this procedure.This is the same microcatheter that was described as ¿the tip of the microcatheter was located in the center of the aneurysm; the complaint coil went into the bleb leading to the intraoperative rupture.¿ aneurysm perforation is a known potential adverse event associated with coil embolization procedures.Manipulation of devices in or near the intracranial aneurysm increases the risk of rupturing the fragile aneurysm wall.With the amount of information available and without procedural films, it is not possible to draw a clinical conclusion between the devices and two instances of aneurysm perforation.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device selection, device manipulation, device interaction, and operator technique that may have contributed rather than the design or manufacture of the devices.Based on the information provided, there may have been sudden movement of the microcatheter tip and coil during coil implantation which may have caused the intraoperative aneurysm perforation.Since aneurysm perforation is considered a serious injury and the relationship of the pulserider, galaxy g3 mini coil, and prowler select plus to the aneurysm perforation cannot be clearly established, the event meets mdr reporting criteria for all three devices.Difficulty to detach is a known potential product failure associated with the use of the pulserider anrd system.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the event.However, the detachment difficulty may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the devices.It is not clear whether the detachment cycle light or the battery charge indicator was noted to be flashing on attempt to detach the pulserider.If the battery indicator is flashing red, then the battery is low.If the battery charge indicator starts flashing in red, the detachment process currently in progress can still be carried out to completion.If the detachment cycle light was flashing, then there would have been a steady audible sound as well meaning the connections were not complete.There is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended, however the potential that it could cause or contribute to a death or serious injury, or another significant adverse event is remote.Thus, the detachment difficulty does not meet mdr reporting criteria.The file will be re-reviewed if additional information is received at a later date.This is one of three products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00279, 3008114965-2021-00330, and 3008264254-2021-00005.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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