The healthcare professional reported that during a coil embolization procedure targeting a basilar artery aneurysm, the 36-year-old female patient experienced a ruptured aneurysm.Details of the procedure is as follows: a pulserider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / 3070988613) was used at the bifurcation aneurysm.The orientation of the pulserider was adjusted several times for deployment at the target lesion, and the pulserider anrd was deployed in the appropriate orientation via a prowler select plus microcatheter (catalog and lot# unknown).When contrast agent was used for flow confirmation, it was confirmed that there was a rupture in the aneurysm and the inflow into the extravascular space.The coil(s) was implanted and the clinical course was monitored, and the procedure was completed.A continuous flush was maintained through the microcatheter.It was reported that the patient did not experience serious symptoms, only a mild headache remained.At the time of the complaint initiation, the patient was still hospitalized.There were no problems after the procedure.Additional medical treatment was not performed during the procedure.No further treatment is planned.Per the physician¿s opinion on possible causes of the aneurysm rupture other than the pulserider anrd are the guidewire, a chikai black 14 guidewire (asahi-intecc) and the microcatheter.
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.The expiration date of the device is not known as the device lot number is not available / not reported.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that during a coil embolization procedure targeting a basilar artery aneurysm, the 36-year-old female patient experienced a ruptured aneurysm.Details of the procedure is as follows: a pulserider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / 3070988613) was used at the bifurcation aneurysm.The orientation of the pulserider was adjusted several times for deployment at the target lesion, and the pulserider anrd was deployed in the appropriate orientation via a prowler select plus microcatheter (catalog and lot# unknown).When contrast agent was used for flow confirmation, it was confirmed that there was a rupture in the aneurysm and the inflow into the extravascular space.The coil(s) was implanted and the clinical course was monitored, and the procedure was completed.A continuous flush was maintained through the microcatheter.It was reported that the patient did not experience serious symptoms, only a mild headache remained.At the time of the complaint initiation, the patient was still hospitalized.There were no problems after the procedure.Additional medical treatment was not performed during the procedure.No further treatment is planned.Per the physician¿s opinion on possible causes of the aneurysm rupture other than the pulserider anrd are the guidewire, a chikai black 14 guidewire (asahi-intecc) and the microcatheter.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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 or rupture and headaches are known complications associated with the use of the pulse rider device and are mentioned in the instructions for use (ifu) as such.Both the pulse rider and the prowler devices performed as intended and no new patient consequences have occurred related to the use of the devices.However, the relationship between the pulse rider, the prowler, and the reported event cannot be excluded.Per the physician¿s opinion, ¿possible causes, other than the pulse rider device, are the guidewire and the microcatheter¿.Therefore, the event will be conservatively reported to the fda 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00463.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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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