MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402300

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier and date of birth 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 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.The product analysis team reviewed the photo of the stent device included in the complaint.The review is documented below.[photo review]: one of the photos that accompanied the complaint file shows the tip of the stent already detached from the unit and both ends were seen completely flared, no damages were noted on it (i.E., no kinks , bends, or broken struts).The rest of the device was not seen in the photo.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8639209.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 a stent being stuck in the microcatheter and then being kinked cannot be confirmed through the provided image since no damages were noted in the stent, also, functional, and dimensional tests need to be performed.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00143 and 3008114965-2024-00144.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 a stent-assisted endovascular embolization that was targeting a left middle cerebral artery (mca) aneurysm, the 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) and the 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device (encr402300 / (b)(6)) were placed in the target site.The physician retracted the microcatheter to release the stent, but the stent was stuck in the microcatheter and could not be released.After making several attempts, the stent still failed to release.The physician removed the microcatheter and the stent from the patient and observed that the stent body was kinked / bent.New devices were used as replacement to complete the procedure.There was no report of any negative patient impact.Five (5) photos were included in the complaint; one is of the stent component.The other four (4) photos are of the packaging.On 30-jan-2024, additional information was received.Per the information, the patient is a 62-year-old male.The location of the targeted aneurysm was the middle cerebral artery (mca).Continuous flush had been maintained through the microcatheter.Nothing unusual was noted about the system prior to use.The stent component was still on the delivery wire when the device was removed from the patient.There were no visible kinks nor other damages noted on the microcatheter.A new 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device (encr402300) and a new 150cm x 5cm prowler select plus microcatheter of the same product code (606s255x) were used as replacements to complete the procedure.There was no delay in the procedure as a result of the reported issue; the additional information confirmed there was no negative patient impact.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that that the stent was already detached from the unit.The delivery wire was in good condition (i.E., no kinks, bends, or elongations).The introducer was not returned for evaluation.These conditions are consistent with the conditions seen in the provided picture.Microscopic inspection was performed on the stent component.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks); also, it was noted fully expanded, both ends can be noted as completely flared.The issue regarding a stent being stuck in the microcatheter cannot be evaluated through functional testing.The stent must be inside the introducer tube to perform the functional analysis.Additionally, none of the returned components present damages that suggest that they were forcibly advanced.With the limited information available, a conclusive cause cannot be determined; however, it is possible that clinical and procedural factors, including device manipulation and operator technique, may have contributed to the reported failure.At this time, there is no evidence to support that the issue reported in the complaint is a result of a defect inherently related to the device.The issue regarding a stent being kinked was not confirmed since such condition was not found on the returned component.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8639209.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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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: 3008114965-2024-00143 and 3008114965-2024-00144.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 complaint device on 20-mar-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00143 and 3008114965-2024-00144.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 multiple attempts were made to obtain the product for evaluation and analyses were unsuccessful.If the product is returned or information is provided at a later date, the complaint file will be updated and the product investigation will be performed and a supplemental 3500a report will be submitted.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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8639209.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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: 3008114965-2024-00143 and 3008114965-2024-00144.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: ENTERPRISE2 4MMX23MM NO 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: 18671629
• MDR Text Key: 336301894
• Report Number: 3008114965-2024-00143
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402300
• Device Lot Number: 8639209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2023
• 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: PROWLER SELECT PLUS 150/5CM
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian