|
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The device lot number is not available / not reported.The expiration date of the device is not known.The implantation date is not known; the patient received the implanted enterprise stent approximately two years prior to the current procedure.The initial reporter information such as first, last names, facility name, facility address, city, phone and email address are not available.The enterprise stent implantation procedure took place approximately two years prior to the current procedure.The device manufacture date is not known as the device lot number is not available / not reported.(b)(4) was chosen to capture the surgical intervention with the use of the neuroscout 14 standard guidewire in the procedure that took place on (b)(6) 2020, with the target stenosis = 50% and within 5mm from the implanted stent.The procedure prompted the use of a competitor stent retriever to remove the detached segment of the guidewire from the patient.[conclusion]: on 03 september 2020, additional information was provided for a procedure that took place on (b)(6) 2020, targeting an intracranial artery stenosis.The healthcare professional reported that during this procedure, the target location was within 5mm from the previously implanted stent.The stenosis was = 50%.The target site was on the left side of the brain; and ¿the stent was narrow side.¿ approximately two years ago, the patient had a 4.0mm x 23mm enterprise® 2 vascular reconstruction device (enc402312 / lot# unknown) implanted.During the procedure on (b)(6) 2020, the physician tried to pass the 0.014in.X 205cm neuroscout 14 standard guidewire (601314 / j6918n) through the previously implanted stent, and he felt a little force, but he thought it was within ¿reasonable scope.¿ after about 6 cm of the guidewire tip came into the stent, the guidewire fractured and separated 13cm from its distal tip.The detached segment of the guidewire embolized in the middle cerebral artery (mca).This prompted the use of a competitor stent retriever to remove the detached segment of the guidewire from the patient.The event resulted in an approximately one-hour procedural delay.There was no observable clinical symptoms or changes in symptoms identified in the patient.The procedure was completed with a competitor guidewire.It was reported that the neuroscout guidewire was inspected prior to use and no damage was observed.The guidewire did not bend nor kink prior to the reported fracture / separation.The guidewire tip was re-shaped prior to use.The guidewire was not inserted through a stopcock instead of a hemostatic valve.The guidewire introducer was used to aid the introduction of the guidewire into the sl-10® microcatheter (stryker) where it was advanced without difficulty.A 6f envoy guiding catheter was also used in conjunction with the device.The guidewire was not torqued against resistance, and the tip of the guidewire did not become fixed within the vasculature.It was reported that an adequate flush had been maintained through the devices.The physician refused to disclose what he/she thinks caused or contributed to the wire fracture / separation.Imaging from the procedure on (b)(6) 2020 was included and was forwarded to independent physician for review on (b)(6) 2020.¿the complaint form is accompanied by a fluoroscopic image of the wire in the patient and a photo of the wire fragment.The physician reports some issues navigating the wire past a previously placed stent.It is unclear why the wire fractured.Wires can fracture from excessive torqueing, particularly if the distal end of the wire is stationary and cannot rotate freely.It is not clear the exact cause of the wire fracture, however, is likely related to the difficulty in wire navigating through the stent.¿ physician name and date reviewed: (b)(6) md, (b)(6) 2020.Additional event information was received on 04 september 2020.The information indicated that the patient had the 4.0mm x 23mm enterprise® 2 vascular reconstruction device (enc402312) implanted two years prior to treat an arterial stenosis.The information also indicated that the current procedure with the neuroscout was targeting a stenosis on the left middle cerebral artery (mca).Based on complaint information, the device remains implanted and is thus not available for evaluation.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.Stenosis of stented segment is a well-known potential adverse event following stent implantation and is listed in the enterprise 2 instructions for use (ifu) as such.The enterprise 2 vascular reconstruction device (vrd) is intended for use with occlusive devices in the treatment of intracranial aneurysms.It is not intended for use as a stand-alone device, i.E.Without subsequent coil embolization of the aneurysm.Experience with stent implants indicates that there is a risk of stenosis.Underlying patient and procedural factors may play a role in the intimal hyperplasia; however, based on the available information, no conclusion can be made regarding the reported event.Since the arterial stenosis being treated was = 50% and was within 5mm of the previously placed enterprise 2 stent, the event meets mdr reporting criteria.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 of failure to detach 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: 3008114965-2020-00392.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.
|
|
On 03 september 2020, additional information was provided for a procedure that took place on (b)(6) 2020, targeting an intracranial artery stenosis.The healthcare professional reported that during this procedure, the target location was within 5mm from the previously implanted stent.The stenosis was = 50%.The target site was on the left side of the brain; and ¿the stent was narrow side.¿ approximately two years ago, the patient had a 4.0mm x 23mm enterprise® 2 vascular reconstruction device (enc402312 / lot# unknown) implanted.During the procedure on (b)(6) 2020, the physician tried to pass the 0.014in.X 205cm neuroscout 14 standard guidewire (601314 / j6918n) through the previously implanted stent, and he felt a little force, but he thought it was within ¿reasonable scope.¿ after about 6 cm of the guidewire tip came into the stent, the guidewire fractured and separated 13cm from its distal tip.The detached segment of the guidewire embolized in the middle cerebral artery (mca).This prompted the use of a competitor stent retriever to remove the detached segment of the guidewire from the patient.The event resulted in an approximately one-hour procedural delay.There was no observable clinical symptoms or changes in symptoms identified in the patient.The procedure was completed with a competitor guidewire.It was reported that the neuroscout guidewire was inspected prior to use and no damage was observed.The guidewire did not bend nor kink prior to the reported fracture / separation.The guidewire tip was re-shaped prior to use.The guidewire was not inserted through a stopcock instead of a hemostatic valve.The guidewire introducer was used to aid the introduction of the guidewire into the sl-10® microcatheter (stryker) where it was advanced without difficulty.A 6f envoy guiding catheter was also used in conjunction with the device.The guidewire was not torqued against resistance, and the tip of the guidewire did not become fixed within the vasculature.It was reported that an adequate flush had been maintained through the devices.The physician refused to disclose what he/she thinks caused or contributed to the wire fracture / separation.Imaging from the procedure on (b)(6) 2020 was included and was forwarded to independent physician for review on (b)(6) 2020.¿the complaint form is accompanied by a fluoroscopic image of the wire in the patient and a photo of the wire fragment.The physician reports some issues navigating the wire past a previously placed stent.It is unclear why the wire fractured.Wires can fracture from excessive torqueing, particularly if the distal end of the wire is stationary and cannot rotate freely.It is not clear the exact cause of the wire fracture, however, is likely related to the difficulty in wire navigating through the stent.¿ physician name and date reviewed: (b)(6) md, (b)(6) 2020.Additional event information was received on 04 september 2020.The information indicated that the patient had the 4.0mm x 23mm enterprise® 2 vascular reconstruction device (enc402312) implanted two years prior to treat an arterial stenosis.The information also indicated that the current procedure with the neuroscout was targeting a stenosis on the left middle cerebral artery (mca).
|
