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Catalog Number ET007533 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
Injury
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Event Description
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The event was reported via social media that during an endovascular thrombectomy procedure to treat an acute stroke, the 5mm x 33mm embotrap ii revascularization device (et007533 / lot# unknown) ¿got detached with the pusher wire while retrieving clot from the artery.¿ the report confirmed that the embotrap ii device became separated in the patient and additional surgical intervention via the use of a solitaire¿ stent retriever (medtronic) to remove the fragmented part of the embotrap ii device was required.There was a 20-minute delay in the procedure as a result of the reported issue.The procedure was reported as successfully completed.It was reported that, the embotrap ii device was reused, ¿and this was his third patient.¿ on 05-oct-2023, further follow-up resulted in the following information, per the additional information, it was confirmed that the embotrap ii device used in this procedure was not a new device.The embotrap ii had been used in ¿3-4 other patients: and the physician ¿does not know how many passes he has done with this [embotrap ii device] but he has given the feedback that after 7-8 passes, the locking mechanism got loosen and he has suggested if we [device manufacturer] can do something better on the proximal detachment part.¿ on 11-oct-2023, additional information was received.The information confirmed that the same embotrap device was re-used on three (3) different patients, ¿for a cumulative 7-8 passes.¿ per the additional information, this is common practice in the hospital.The sterilization process used is ethylene oxide (eto) sterilization.On 18-oct-2023, additional information was received.The information indicated that the physician used the embotrap ii device on multiple patient because, ¿it¿s their practice because of non-affordability of patients.¿ for the procedure associated with this complaint, the information indicated that ¿hopefully, it is the fourth patient¿ that the device was used in.The issue reported in the complaint, that the stent detached from pusher wire occurred on the second pass.The information indicated that the device is reprocessed via ethylene oxide sterilization (eto).After eto sterilization, the device gets stored on ¿their shelves.¿ pertaining to the procedure associated with this complaint, it was targeting a middle cerebral artery (mca) occlusion.The clot characteristics is described as follows: ¿ it was [red blood cell] rbc and [white blood cell] wbc missed clot; entire stent was full of clot.¿ there was excess vessel tortuosity / acute bends in the target vessel.The concomitant microcatheter used was a phenom¿ microcatheter (medtronic).Per the additional information, the microcatheter was not used on multiple patients.Excessive force was applied to the embotrap ii device ¿because the anatomy was very tortuous.¿ the patient¿s post-procedure status was not reported.The information indicated the device is available for return.The additional information also included five (5) images.Two (2) images are procedure images.The three (3) remaining are photos of the device.Procedure images and photos of the device will undergo independent physician review.The product analysis team will review the device photos.On 19-oct-2023, additional information was received stating that the lot number of the embotrap ii device is not available.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.Section e.1: the initial reporter phone and email address are not available / reported.Section h.3: 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.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.The product analysis lab team reviewed the three (3) photos of the device included in the complaint.The review is documented below.[photo review ¿ summary]: it was reported that the embotrap stent detached in the patient¿s vessel during retrieval.Review of the provided photographs showed evidence of detachment of the stent portion of embotrap from the nitinol wire, and interaction with a second stent retriever of different make (not identified).The event is therefore confirmed.The images provided confirmed there was no fracture of struts of the outer cage or inner channel.The two components are assembled to the nitinol wire by mechanical lock and adhesive bond.The elements of the outer cage or inner channel that form the mechanical lock (proximal collar and half-round collar respectively) appeared intact.Therefore, it can be concluded that the mechanism of detachment is failure of the adhesive bond.It was reported that the same unit was previously used on two other patients and sterilized by eto cycle in between patients.It was also reported that after a cumulative number of 7 or 8 passes, they observed loosening of the proximal bond.The embotrap device is designed and validated for single use (i.E.Use on a single patient and procedure) and for a maximum of three passes.The embotrap device is not indicated for re-sterilization by the end user.Appropriate symbology is included in the label (¿do not re-use¿ symbol per iso 15223-1) and warnings are included in the ifu ("this device is for use in one patient only.Do not resterilize or reuse in more than one patient.Reusing the device in another patient could result in compromised device performance, cross infection, and other safety related hazards.¿ and ¿do not use any embotrap ii revascularization device more than 3 times.¿ additionally, the ifu recommends inspecting the device prior to use and to not use in case any damage of deformity is observed.The adhesive used in the proximal bond (between stent assembly and nitinol shaft) is normally in contact with fluid at body temperature for a short period lasting minutes during the procedure, the ifu states that the device may be left to embed in the clot 3-5 minutes prior to withdrawal of the device.As the returned device was reused as multiple times and re-sterilized twice by eto cycles, the bond was over exposed to fluid, humidity, and high temperatures, possibly over a time span of multiple days, and this may have impacted the adhesive bond and contributed to failure of the same and separation of the stent assembly from the nitinol shaft.Under normal use this is not applicable, as a new device is opened for each procedure, and the procedural time would not be long enough to cause this affect.Additionally, multiple use of the device (7 or 8 passes) across the three patients would result in over exposure of the proximal bond to axial force during insertion and removal, potentially contributing to failure of the adhesive, loosening of the bond and ultimately separation of the stent assembly.Other potential factors (e.G., patient specific factors such as anatomy or calcifications) could not be evaluated based on the details and pictures provided.Therefore, while the event is confirmed, the root cause cannot be determined.Conclusion: the review of the provided photographs confirmed detachment of the embotrap stent portion from the nitinol wire.There was no evidence of further damage or defects present on the device in the provided photographs.Repeated use of the device on multiple patients and re-sterilization are considered potential contributing factors to the event, however the root cause of this complaint event cannot be determined from the provided photographs.The proximal coil of the embotrap ii separated from the device during use in the patient, which could potentially result in vessel damage, embolization, ischemia, or infarct, and/or the need for additional intervention.In this case, an additional surgical intervention was required to remove the fragmented part of the embotrap to preclude patient harm.However, it is paramount to note that the embotrap ii device was not used accordingly to the instructions for use (ifu), which could have attributed to the event.Per the ifu, the embotrap ii device is for single use only, and is designed to withstand up to three retrieval attempts in the same vessel.Should the user observe any damage or deformity, before or during the use of the device, the user should not use the device, and should use a new embotrap ii device instead.Additionally, the use of a single-use medical device in multiple patients can likely compromise the safety of the patients.As explained in the referenced literature article, reusing single-use medical devices can lead to serious consequences for the patient, including cross infection, compromised performance of the device (including chemical corrosion of the device resulting from the sterilization process), injury, and ineffective care.The severity of this event is unknown.Additionally, the event resulted in a 20-minute delay of the surgical procedure.Based on this information, this event does meet us fda reporting criteria under 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.Reference: gautam, d., sahney, r., et al.Reprocessing and reuse of single-use medical devices and the role of interprofessional collaboration: a literature review.Current medicine research and practice.10(2).2020.Pp.70-74, issn 2352-0817.Https://doi.Org/10.1016/j.Cmrp.2020.03.001.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.(b)(4).The purpose of this mdr submission is to include the medical image review completed on 15-nov-2023.The procedure image included in the complaint underwent independent physician review.The assessment is documented below.¿the images provided do not provide an explanation for the detachment of the device from the pusher wire.The use of the device in multiple patients is contraindicated as per the ifu and damage resulting from handling in between patients cannot be excluded to be the cause of the detachment.The returned product may provide more insight when analyzed by the r&d team.¿ physician name and date reviewed: (b)(6) 2023.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 12-dec-2023.[additional information]: on 12-dec-2023, additional information was received.Per the information, the 5mm x 33mm embotrap ii revascularization device is not available for return.Based on complaint information, the device is not available to be returned for analysis.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.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.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.Updated sections: b.4, g.3, g.6, h.2, h.3, h.6, and h.10.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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