MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X14MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451412

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, and weight, were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: the remainder of the device component 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.The product analysis team reviewed the photo of the device component included in the complaint.The review is documented below.[photo review]: the photo shows the distal tip of the delivery wire separated from the rest of the wire.In addition one kink was noted in the wire near the retraction bump.The rest of the device is not shown in the photo.No further damage could be noted.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8512168.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The issue regarding the distal tip of the delivery wire being separated was confirmed.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.A fractured wire while in-patient, may separate and then embolize, resulting in ischemia or infarct.In this case, the event required the additional surgical intervention of using a competitor brand wire to pull the broken section out of patient.In addition, the surgical procedure was prolonged by 40 minutes.The severity of the event and patient outcome are unknown.Based on this information, this event meets us fda reporting criteria 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.Per the additional information received on 28-feb-2024, it was confirmed there were no patient consequences as a result of the event and the physician did not consider the 40-minute procedure extension to be clinically significant.However, because the event required an additional surgical intervention of using a competitor brand wire to pull the broken section out of patient, this event remains reportable to the usfda, reporting under criteria 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.

Event Description

The healthcare professional reported that during an angioplasty procedure, the 4.5mm x 14mm enterprise vascular reconstruction device (enc451412 / 8512168) was implanted and released in the patient after balloon dilation.The physician then withdrew the delivery wire of the stent.The digital subtraction angiography (dsa) revealed that an area of the distal tip of the delivery wire and stent positioning marker was fractured / separated in the patient¿s body.The physician used a competitor brand wire to pull the broken section out.The procedure was prolonged by approximately 40 minutes.The delivery wire of the stent was discarded; only the broken section is reportedly available to be returned.There was no report of any patient injury.The complaint included one photo of the device component, one procedure image, and one mp4 video clip of the procedure.The procedure image and video will undergo independent physician review.On 28-feb-2024, additional information was received.The information indicated that the patient is a 47-year-old male; the target vessel was the m1 segment of the left middle cerebral artery (mca).The concomitant microcatheter used to deliver the enterprise stent to the target site was a 150/5cm prowler select plus (606s255x / 31154821).Information related to whether there was resistance during advancement of the stent through the microcatheter was not obtainable.Continuous flush was maintained through the microcatheter.The delivery wire was not reshaped prior to use.It is not known if the stent had been retracted / recaptured prior to the final release for implantation.There was appropriate size selection related to the device used; the enterprise stent length was selected that there was at least 10mm longer than the aneurysm neck to maintain a minimum of 5mm on either side of the aneurysm neck.There was no evidence of obstructed blood flow due to the reported issue.The physician did not consider the 40-minute procedure extension to be clinically significant; per the information, during the 40-minute, the physician used a competitor wire to pull out the broken section.There was no negative impact to the patient.The information indicated that the procedure was successfully completed after the fractured piece was removed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the medical image review completed on 13-mar-2024.The procedure image and the mp4 video clip of the procedure included in the complaint underwent independent physician review.The assessment is documented below.¿from the description it is assumed that the delivery wire broke off and the distal portion remained in situ after stent deployment.The video supplied supports this event and the image provided shows the balloon dilatation that took place before stent deployment.One feature observed in this still image is the sharp angle of the guidewire, supporting the balloon, when it exits the distal access catheter on the lower end of the image.This suggests that there is either a tight stenosis, vasospasm or curve in this area.Unfortunately the image is one directional, which makes a 3d assessment impossible.The video shows the attempt to remove the distal wire.Since the cause of the break cannot be clearly assessed, based on the footage provided, further analysis of the retrieved wire may help finding the root cause.Potential reasons for the break, apart from material failure, could be the sharp angle coming out of the support catheter or any other outside force working on the pusher wire.¿ physician name and date reviewed: (b)(6) 2024.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the remainder of the device component associated with the complaint device on 01-apr-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

• Brand Name: EU 4.5X14MM STENT 12 MM DW TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18881955
• MDR Text Key: 337409123
• Report Number: 3008114965-2024-00269
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC451412
• Device Lot Number: 8512168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER (UNSPECIFIED BRAND); PROWLER SELECT PLUS 150/5CM
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian