MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X28MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452812

Device Problems Break (1069); Premature Activation (1484); Failure to Advance (2524)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).Section h3 - 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.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.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00113.

Event Description

As reported by the field, during the procedure, an eu 4.5x28mm stent 12 mm dw tip intracranial stent (enc452812, 8219132) became impeded in y connector and could not be pushed into the prowler select plus 150/5cm microcatheter (606s255x, 31018682).The physician retracted the stent, but it was released automatically.The stent body was separated prematurely from the delivery wire, and the stent body was found to be fractured.The doctor removed the microcatheter (mc) from the patient and switched new stent and microcatheter to complete the surgery.There was no patient injury.Additional event information was received on 17-jan-2024 indicating that they were able to torque the device.There was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.The mc did not kink or bent.No excessive force used with the stent.There were no procedural delays due to the event.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during the procedure, an eu 4.5x28mm stent 12 mm dw tip intracranial stent (enc452812, 8219132) became impeded in y connector and could not be pushed into the prowler select plus 150/5cm microcatheter (606s255x, 31018682).The physician retracted the stent, but it was released automatically.The stent body was separated prematurely from the delivery wire, and the stent body was found to be fractured.The doctor removed the microcatheter (mc) from the patient and switched new stent and microcatheter to complete the surgery.There was no patient injury.Additional event information was received on 17-jan-2024 indicating that they were able to torque the device.There was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.The mc did not kink or bent.No excessive force used with the stent.There were no procedural delays due to the event.Two pictures were attached to the complaint file, in which the detached stent was shown.It was noticed that one of the ends has a bent strut.Also, the stent was noted to have some broken struts.The other end was noted without damage and it can be noted as completely flared.The rest of the delivery system was not shown in the picture.A non-sterile eu 4.5x28mm stent 12 mm dw tip intracranial was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the introducer was not returned for evaluation.As seen in the provided picture the stent was already detached from the unit.No damages were observed on the delivery wire.The stent component was inspected under microscopic magnification, and one of the ends was noted to be completely flared; however, the other end was found to have one strut broken.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 reported issues can be confirmed based on the damage found in the stent, which suggests that the device was subjected to certain manipulation that could also have caused the stent to disengage from the delivery wire which ultimately resulted in the stent 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.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8219132.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EU 4.5X28MM 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 ; 3035526892
• MDR Report Key: 18562275
• MDR Text Key: 333455915
• Report Number: 3008114965-2024-00112
• 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,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452812
• Device Lot Number: 8219132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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