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Manufacturers ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not available.[conclusion]: the healthcare professional reported that during a pulserider-assisted coil embolization of an unruptured basilar tip aneurysm in a female patient, a pulserider 8t, 2.7 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3051697019) was allegedly deployed as per the instructions for use (ifu) in a hybrid position from the right posterior cerebral artery (pca) to the aneurysm (i.E., partially intraaneurysmal).A concomitant sl-10¿ microcatheter (stryker) used for coil delivery was advanced to the aneurysm via trans-cell approach.A 4mm x 10cm galaxy g3 coil was used but the size did not fit so it was replaced with a 3mm x 8cm galaxy g3 coil.However, coil was deemed too small for the aneurysm.The coil was replaced with a 3.5mm x 9cm galaxy g3 coil (gly123509 / lot#: unknown).The coil was rewinded multiple times, but it was not able to frame the aneurysm as intended.The coil was replaced with a 3mm x 6cm competitor coil, but it was also not able to be winded as intended.Therefore, the competitor coil was removed as well.The guidewire (brand not specified) was reinserted, and the physician changed the position of the microcatheter.However, angiography confirmed that bleeding occurred from the end of the perforator of the right pca.Protamine was injected and heparin reversal was performed.The pulserider anrd which had deployed was removed.A shouryu balloon catheter (kaneka medix) was inserted, inflated, and deflated at the right pca several times.The physician tried to achieve hemostasis, but bleeding did not stop.The sl-10 microcatheter was delivered to the right pca to embolize the mother vessel of the right pca because the posterior communicating artery (pcom) had developed.Repeat angiography confirmed bleeding of the main right pca.The right pca was embolized with coil (s) and endovascular therapy was performed.The patient was taken to the operating room for emergent craniotomy.It was last reported that the patient has been hospitalized.Her current health status is not known.On 02 july 2021, the reporting sales representative requested the addition of four coils deemed related to the reported bleed: three (3) 3mm x 8cm galaxy g3 (gly120308) from three lots: (l16581, l16136, and 30498789) and one (1) 4mm x 10cm galaxy g3 (gly120410 / 30393960).There were no malfunctions associated with these coils.On 12 july 2021, additional information was received.The information indicated that the physician reported that the pulserider and cerenovus coils were not the cause of the reported event.There was no unintended movement of the pulserider device at any time during the procedure.There was no report of device damage.The physician could not frame the 3.5mm x 9cm galaxy g3 coil as intended.It was reported that there was no difficulty getting the coil to conform to the aneurysm wall.On 21 july 2021, via a phone call conducted with the (b)(6) affiliate.She stated that on (b)(6) 2021, the reporting physician told the sales representative that the hemorrhage occurred due to vascular anomalies of the patient and the j&j devices were not related to the hemorrhage.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (3051697019) 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.Vascular injury, and hemorrhage requiring additional intervention are known potential procedural complications associated with the galaxy g3 coil.Vascular sequelae including dissection, perforation, or other trauma, and hemorrhage 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 devices 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 devices.The treating physician felt that the hemorrhage was secondary to vascular anomalies of the patient.Nevertheless, the relationship of the devices to the reported event cannot be clearly established.Therefore, the event meets mdr reporting criteria for the pulserider and five galaxy g3 coils with the classification of serious injury.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 six products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00271, 3008114965-2021-00293, 3008114965-2021-00294, 3008114965-2021-00295, and 3008114965-2021-00296.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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The healthcare professional reported that during a pulserider-assisted coil embolization of an unruptured basilar tip aneurysm in a female patient, a pulserider 8t, 2.7 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3051697019) was allegedly deployed as per the instructions for use (ifu) in a hybrid position from the right posterior cerebral artery (pca) to the aneurysm (i.E., partially intraaneurysmal).A concomitant sl-10¿ microcatheter (stryker) used for coil delivery was advanced to the aneurysm via trans-cell approach.A 4mm x 10cm galaxy g3 coil was used but the size did not fit so it was replaced with a 3mm x 8cm galaxy g3 coil.However, coil was deemed too small for the aneurysm.The coil was replaced with a 3.5mm x 9cm galaxy g3 coil (gly123509 / lot#: unknown).The coil was rewinded multiple times, but it was not able to frame the aneurysm as intended.The coil was replaced with a 3mm x 6cm competitor coil, but it was also not able to be winded as intended.Therefore, the competitor coil was removed as well.The guidewire (brand not specified) was reinserted, and the physician changed the position of the microcatheter.However, angiography confirmed that bleeding occurred from the end of the perforator of the right pca.Protamine was injected and heparin reversal was performed.The pulserider anrd which had deployed was removed.A shouryu balloon catheter (kaneka medix) was inserted, inflated, and deflated at the right pca several times.The physician tried to achieve hemostasis, but bleeding did not stop.The sl-10 microcatheter was delivered to the right pca to embolize the mother vessel of the right pca because the posterior communicating artery (pcom) had developed.Repeat angiography confirmed bleeding of the main right pca.The right pca was embolized with coil (s) and endovascular therapy was performed.The patient was taken to the operating room for emergent craniotomy.It was last reported that the patient has been hospitalized.Her current health status is not known.On 02 july 2021, the reporting sales representative requested the addition of four coils deemed related to the reported bleed: three (3) 3mm x 8cm galaxy g3 (gly120308) from three lots: (l16581, l16136, and 30498789) and one (1) 4mm x 10cm galaxy g3 (gly120410 / 30393960).There were no malfunctions associated with these coils.On 12 july 2021, additional information was received.The information indicated that the physician reported that the pulserider and cerenovus coils were not the cause of the reported event.There was no unintended movement of the pulserider device at any time during the procedure.There was no report of device damage.The physician could not frame the 3.5mm x 9cm galaxy g3 coil as intended.It was reported that there was no difficulty getting the coil to conform to the aneurysm wall.On 21 july 2021, via a phone call conducted with the (b)(6) affiliate.She stated that on (b)(6) 2021, the reporting physician told the sales representative that the hemorrhage occurred due to vascular anomalies of the patient and the j&j devices were not related to the hemorrhage.
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