MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 28MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENC452800
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
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.The purpose of this mdr submission is to report the findings of the device investigation.Based on the product analysis of the device received, the stent has an unexpected fold or twist and was found broken.The findings meet us regulatory reporting criteria.A non-sterile eu ent4.5mmd 28mml wno dstl tp was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and only the stent was returned for analysis.One strut of the stent was noted to be bent.Microscopic inspection was performed, and the bent strut was found also broken.Despite of this, the stent was noted to be fully expanded, both ends were note 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 impeded in the introducer 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.However, the complaint 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 bent/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.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.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.
Event or Problem Description
The healthcare professional reported that the eu ent4.5mmd 28mml wno dstl tp (enc452800/8598551) was impeded in introducer and could not be pushed into the microcatheter.The physician retracted the stent and switched to a new one to complete the surgery.The microcatheter (mc) was not replaced.There was no patient injury report.Additional event information received on (b)(6) 2024 indicated that the microcatheter used was prowler select plus.The device did not appear damaged at any time.Nothing was noted to be obstructing the introducer.A continuous flush 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 patient injury reported.Based on the product analysis of the device received, the stent has an unexpected fold or twist and was found broken.

• Brand Name: EU ENT4.5MMD 28MML WNO DSTL TP
• 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: 20302993
• Report Number: 3008114965-2024-00945
• Device Sequence Number: 8712215
• Product Code: NJE
• UDI-Device Identifier: 10886704071785
• UDI-Public: (01)10886704071785(17)250828(10)8598551
• 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
• Report Date (Section B): 09/25/2024

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: 08/28/2025
• Device Catalogue Number: ENC452800
• Device Lot Number: 8598551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2023
• 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 150/15CM
• Patient Sex: Unknown