MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 20MM X 60CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF182060
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
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 is 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 (31178151) 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 product 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 device; 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 procedure with the target located on the inferior mesenteric artery (ima) and the left internal iliac artery (iia) prior to stent graft implantation, a 5 fr diagnostic catheter and a coiling support microcatheter were used.Coil embolization of the ima was initiated.The first coil used was a 5mm x 20cm deltafill 18 (dlf180520 / 30910234), but the coil protruded from the middle of the introducer sheath during advancement.An unsuccessful attempt to retrieve the coil was made; the coil was stuck at the sheath and re-sheathing was difficult.This coil was then replaced and the replacement coil was successfully implanted with no issues.Three additional cerenovus coils were implanted and the coil embolization for the left iia was initiated.The 20mm x 60cm deltafill 18 (dlf182060 / 31178151) was used as the second coil in the iia.The entire coil was confirmed under fluoroscopy to have exited from the microcatheter (unspecified brand) and an attempt to detach the coil was made, but the coil could not detach.The detachment control was rebooted and another unsuccessful attempt to detach the coil was made.The coil was retrieved and a third attempt to detach was made, but the signal was not heard and the coil was not detached.It was replaced and the replacement coil was implanted without any problems.The procedure was successfully completed with a total of 5 coils implanted to the iia; it was confirmed by angiography.There was no report of any negative patient impact.On 05-mar-2024, additional information was received.Per the information, continuous flush was maintained through the microcatheter.The second coil was successfully removed from the patient.Clarifying information was received related to the detachment attempts.A third attempt was made to detach the second coil; there was no third coil.The detachment system was rebooted and attempts to detach the second coil was made repeatedly but the coil could not detach.The coil was retrieved and replaced with a new coil which was then implanted without any issues.

• Brand Name: DELTAFILL18 20MM X 60CM
• 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: 18923989
• Report Number: 3008114965-2024-00272
• Device Sequence Number: 18021235
• Product Code: KRD
• UDI-Device Identifier: 10886704077169
• UDI-Public: 10886704077169
• 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
• Report Date (Section B): 03/18/2024

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: DLF182060
• Device Lot Number: 31178151
• 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: 03/01/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND).
• Patient Sex: Unknown