MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERENOVUS ENTERPRISE; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENC452812
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during an endovascular embolization, an eu 4.5x28mm stent 12 mm dw tip intracranial stent (enc452812, 8546184) became impeded in introducer and could not be pushed into microcatheter.The physician removed the stent and the prowler select plus 150/5cm microcatheter (606s255x, 31211760) from the patient and switched to new devices to complete the procedure.The surgery was prolonged about 10 minutes.No patient injury was reported.Additional event information was received on 08-nov-2024 indicating that they were not able to torque the device.There was no evidence of physical material within the device.The microcatheter did not kink/bent.There was no excessive force used with the devices.The 10 minutes procedural delay was not clinically significant.
Additional 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.If the device returns, a device investigation will be performed.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch report: b4, g3, g6, h2, h3, h6 and h11.Based on further review of the event description, the delivery wire was impeded in introducer.The event does not meet us regulatory reporting criteria.A non-sterile eu 4.5x28mm stent 12 mm dw tip intracranial stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the distal end of the delivery wire was partially out of the proximal end of the introducer; however, no damages were observed.A functional test was attempted; however, the stent could not be advanced nor retracted from the introducer.Microscopic inspection was performed, and the stent was found disengaged from the delivery wire at the distal end.The distal inner diameter (id) and outer diameter (od) of the introducer were measured and found within specifications.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.The issue reported regarding the stent being impeded in the introducer was confirmed based on the findings mentioned above.With the limited information available and the evidence obtained from the device inspection, there is no clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.The disengaged condition of the stent suggest that it was inadvertently moved during the attempts to advance or retract the stent from the introducer.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.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 caution and 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: CERENOVUS ENTERPRISE
• Common Device Name: 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: 20641086
• Report Number: 3008114965-2024-01088
• Device Sequence Number: 12634708
• Product Code: NJE
• UDI-Device Identifier: 10886704044031
• UDI-Public: (01)10886704044031(17)250728(10)8546184
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2025
• Device Catalogue Number: ENC452812
• Device Lot Number: 8546184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/11/2024; 12/18/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/11/2024; 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT PLUS 150/5CM.
• Patient Sex: Unknown