MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 3MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180312
Medical Device Problem Codes	Failure to Advance (2524); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
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.Procode: krd/hcg.(b)(6).Complaint conclusion: as reported by the field, this was a coil embolization at the inferior mesenteric artery before placement of a stent graft for abdominal aortic aneurysm.The complaint coil, a deltafill18 3mm x 12cm (dlf180312, 30490114) was used but it got stuck in a carnelian microcatheter, marvel.It was about to be retrieved but it was detached in the microcatheter (mc).The catheter was retrieved together, and a new product was used for embolization.It was unclear if continuous flush was done.Additional information received indicated that replaced coil was used together with the mc.Nothing was obstructing the microcatheter.No excessive force was applied to the device.The device was removed from the patient without additional intervention.There was no microcatheter damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.There was no damage to the actual coil.There was no prolongation during the procedure due to the event.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30490114 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaints of coil  premature detachment in microcatheter and detachable coil delivery system - impeded in microcatheter with no loss of cerebral target position could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the events are related to the device manufacturing process.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Premature detachment and impeded in microcatheter are known potential procedural complications associated with the deltafill18 coil.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of unintended detachment.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 events were 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, this was a coil embolization at the inferior mesenteric artery before placement of a stent graft for abdominal aortic aneurysm.The complaint coil, a deltafill18 3mm x 12cm (dlf180312, 30490114) was used but it got stuck in a carnelian microcatheter, marvel.It was about to be retrieved but it was detached in the microcatheter (mc).The catheter was retrieved together, and a new product was used for embolization.It was unclear if continuous flush was done.Additional information received indicated that replaced coil was used together with the mc.Nothing was obstructing the microcatheter.No excessive force was applied to the device.The device was removed from the patient without additional intervention.There was no microcatheter damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.There was no damage to the actual coil.There was no prolongation during the procedure due to the event.

• Brand Name: DELTAFILL18 3MM X 12CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12506785
• Report Number: 3008114965-2021-00467
• Device Sequence Number: 12008611
• Product Code: KRD
• UDI-Device Identifier: 10886704077190
• UDI-Public: 10886704077190
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 11/30/2023
• Device Model Number: DLF180312
• Device Catalogue Number: DLF180312
• Device Lot Number: 30490114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARNELIAN MICROCATHETER, MARVEL