MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF100308
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).The purpose of this mdr submission is to document the findings of the device investigation.The embolic coil was found to be kinked, which meets the applicable regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.The device was returned to j&j medtech for further evaluation.A non-sterile deltafill10 3mm x 8cm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the coil was returned outside the introducer.Under magnification, the embolic coil was found to be kinked.However, it remained attached to the resistance heating (rh).No other damage was noted in the device.The issue documented a coil that the coil could not be inserted into the microcatheter was confirmed based on the appearance of the returned device.The damage observed in the coil could be the result of the impeded condition experienced during the procedure.Kinking can occur during procedure handling where force may have been inadvertently applied.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement due to continuous saline flush not being established, which can result in coil damage.Coil kinking is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.There is no indication that the issue reported is a result of a defect inherently related to the device.A manufacturing record evaluation was performed for the finished device 2232541s number, and no internal actions related to the malfunction were identified.As part of j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no internal action is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) contain the following precautions: if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.If repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.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 report is being submitted pursuant to the provisions of 21 cfr, part 803.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
It was reported that during an endovascular embolization, two deltafill10 2mm x 8cm coils (product codes: dlf100208, lot numbers: 2232554s and 2232541s) and a deltaxsft10 2mm x 4cm coil (product code: dlx100204, lot number: 2022553s) could not be inserted into the echelon10, medtronic microcatheter (mc).Additional event information indicated that another delatafill and deltaxsft coils were successfully used with the microcatheter.There was no need to remove or replace the microcatheter during the procedure.The target vessel was the middle cerebral artery (mca), and specific anatomical characteristics¿including calcification, tortuosity, and vessel diameter¿were not available.Throughout the intervention, there were no observations of physical damage to the devices, and no obstructions within the microcatheter were noted.A continuous flush was maintained for the duration of the procedure.Based on the product analysis of the returned device, the embolic stent was kinked.

• Brand Name: DELTAFILL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24392938
• Report Number: 3008114965-2026-00311
• Device Sequence Number: 10257830
• Product Code: KRD
• UDI-Device Identifier: 10886704077046
• UDI-Public: (01)10886704077046(17)280831(10)2232541S
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: DLF100308
• Device Lot Number: 2232541S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2025
• 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: ECHELON¿ MICRO CATHETER (MEDTRONIC).
• Patient Sex: Unknown