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

Catalog Number	ENF403000
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.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 company is seeking this information through the event investigation.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 or Problem Description
As reported by the field, an enterprise2 4mmx30mm no tip intracranial stent (enf403000, 8848362) prematurely deployed on the introducer sheath.There was no patient injury reported.No additional information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).One photo accompanied the complaint file in which a stent component can be detached next to a delivery wire.The introducer was not shown in the picture, and no damages are observed on the stent nor the delivery wire.Microscopic inspection was performed on the stent component.The stent is noted fully expanded, both ends can be noted as completely flared.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 prematurely deployed was confirmed based on the detached condition of the stent shown in the photo provided.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint #(b)(4).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.
Additional Manufacturer Narrative
Product complaint # (b)(4).As reported by the field, an enterprise2 4mmx30mm no tip intracranial stent (enf403000, 8848362) prematurely deployed on the introducer sheath.There was no patient injury reported.No additional information is available.One photo accompanied the complaint file in which a stent component can be detached next to a delivery wire.The introducer was not shown in the picture, and no damages are observed on the stent nor the delivery wire.Microscopic inspection was performed on the stent component.The stent is noted fully expanded, both ends can be noted as completely flared.The device was returned to j&j medtech for further evaluation.A non-sterile enterprise2 4mmx30mm no tip intracranial stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that only the detached stent was returned for evaluation.The stent 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 customer complaint regarding a premature deployment of the stent was confirmed due to the detached condition of the stent; however, with the amount of information available and the lack of returned components, no further investigation can be conducted.It is possible that clinical and procedural factors, including device manipulation, may have contributed to the reported failure.There is no indication that the issues reported in the complaint result from a defect inherently related to the enterprise device.The delivery wire and introducer components might have gotten lost sometime during the post-operative handling of the device.If additional information or components are received at a later time, this investigation will be reassessed accordingly.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.As part of the 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 corrective action 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: 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Updated sections on this med watch report: g3, g6, h2, h3, h6 and h11.

• 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: 20449739
• Report Number: 3008114965-2024-00998
• Device Sequence Number: 15224367
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: (01)10886704075387(17)270128(10)8848362
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 12/12/2024

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 Catalogue Number: ENF403000
• Device Lot Number: 8848362
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 12/05/2024; 12/23/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 10/28/2024; 12/12/2024; 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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
• Patient Sex: Unknown