MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 10MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181040
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30915613) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances 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 information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including 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 at a later time.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.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 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 a coil embolization of a subclavian artery endoleak during a thoracic endovascular aortic aneurysm repair (tevar) procedure, the embolization was performed by ¿plug-in coil technique,¿ a plug was placed into the subclavian artery, and when the physician attempted to place the complaint coil, a 10mm x 40cm deltafill 18 (dlf181040 / 30915613) using microcatheter (coiling support) by plug-in coil, there was resistance in the microcatheter; it was reported that continuous flush was maintained, the coil was retrieved.The coil appeared to have unraveled.The coil itself could be removed entirely and the procedure was successfully completed using four other 10mm x 40cm deltafill 18 coils.There was no negative impact to the patient.On 21-aug-2023, additional information was received.The additional information indicated that an adequate, continuous flush was maintained through the microcatheter.The microcatheter used was a ¿coiling support.¿ the brand was not provided.There was resistance inside the microcatheter and the coil was withdrawn before it reached the target site.The information indicated that the coil was not repositioned because it unraveled.The reported issue occurred during the coil insertion through the microcatheter.The coil was not deployed and it was not repositioned.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 12-sep-2023.Additional information: on 12-sep-2023, limited additional information was received.Per the additional information, there were no kinks on the microcatheter that may have contributed to the issue.The coils were inserted with no issues.The complaint coil was not detached; the whole coil was retrieved.The information indicated that there was no significant delay; the procedure time was extended for coil retrieval.No further information can be obtained.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: DELTAFILL18 10MM X 40CM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 17588365
• Report Number: 3008114965-2023-00566
• Device Sequence Number: 12356089
• Product Code: KRD
• UDI-Device Identifier: 10886704077114
• UDI-Public: 10886704077114
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 09/30/2025
• Device Catalogue Number: DLF181040
• Device Lot Number: 30915613
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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