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

Catalog Number	DLF180625
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone is not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot: (0732535s) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported issue documented in the complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered later.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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during an endovascular coil embolization procedure targeting the inferior mesenteric artery to trat an abdominal aortic aneurysm, which was performed prior to a stent graft placement, the devices were used in accordance with the ifu.After using a diagnostic catheter and microcatheter (coiling support catheter (medicos hirata), the physician checked the electrical continuity of the first coil, a 6mm x 25cm deltafill 18 coil (dlf180625 / 0732535s), but it did not respond.It was replaced with a second 6mm x 25cm deltafill 18 coil (dlf180625) from the same lot: (0732535s).The second coil was placed into the target lesion.After checking the electrical continuity, the physician attempted to detach the coil; ¿a sound was made, but it could not be detached.¿ the second coil was replaced with another 6mm x 25cm deltafill 18 coil (dlf180625) and the new coil was implanted without any issue.The coil embolization of the inferior mesenteric artery was successfully completed.There was no negative impact to the patient.Continuous flush was maintained during the procedure.On 15-jun-2025, additional information was received.Per the information, all connections fit properly without the application of excessive force.The replacement for the second coil was another 6mm x 25cm deltafill 18 (dlf180625).
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 03-jul-2025.[additional information]: on 03-jul-2025, additional information was received.Per the information, when the coils were removed from the patient¿s body, ¿the coil was tightly attached to the catheter surface.¿ the coils were still attached to their respective delivery systems when they were removed.The fault light was not seen during the procedure.Upon pressing the power button, all lights illuminated.The green system ready light did not illuminate.The information indicated that there was an approximate 20-minute delay but whether it was considered clinically significant was not stated; the information indicated that ¿the patient has improved after the procedure.¿ the manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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 ; 949788-2078
• MDR Report Key: 22352671
• Report Number: 3008114965-2025-00544
• Device Sequence Number: 8621856
• Product Code: KRD
• UDI-Device Identifier: 10886704076933
• UDI-Public: (01)10886704076933(17)280229(10)0732535S
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: DLF180625
• Device Lot Number: 0732535S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: COILING SUPPORT CATHETER (MEDICOS HIRATA).
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian