MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403000

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

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4) the purpose of this mdr submission is to report the findings of the device investigation.Based on the product analysis, the stent was found bent, meeting us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.A non-sterile enterprise2 4mmx30mm no tip was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that only the stent component was returned, already detached from the unit.The stent component was inspected under microscopic magnification, and one of the distal ends was noted to be completely flared; however, the other end was found to have the struts bent and broken.As a result of the broken condition, one of the marker bands is missing.The issue reported regarding the stent being impeded in the middle section of the microcatheter could not be evaluated through a functional test; the stent must still be attached to the delivery wire and inside the introducer tube to perform the functional analysis.The damage observed on the stent was not originally reported in the complaint, however, the reported issue can be confirmed based on such damages, which suggest that the device was subjected to certain manipulation that could also have caused the stent to disengage from the delivery wire which ultimately results in the marker band breakage.It is also suggested that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.There is no indication that the issues reported in the complaint are a result of a defect inherently related to the enterprise device.The issue regarding a delivery wire being kinked was not able to be evaluated since the component was not returned for evaluation.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 7516347.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent this type of damages from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.If resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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 information was not provided in the reported event or available at the time of report submission.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.

Event Description

As reported by the field, during a stent assist coil embolization to the middle cerebral artery, an enterprise2 4mmx30mm no tip intracranial stent (encr403000, 7516347) became impeded in the middle section of a prowler select microcatheter (606s255x , unknown lot) and could not advance any more.The physician retracted the stent and observed the delivery wire was kinked/bent.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional information received indicated that a continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force applied to the device.Based on the product analysis of the device received, the stent was found bent.

• Brand Name: ENTERPRISE2 4MMX30MM 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 ; 3035526892
• MDR Report Key: 17986801
• MDR Text Key: 327365589
• Report Number: 3008114965-2023-00758
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403000
• Device Lot Number: 7516347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2022
• 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