MAUDE Adverse Event Report: KANEKA CORPORATION I-ED COIL SYSTEM; DEVICE, NEUROVASCULAR EMBOLIZATION DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	373-040815
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.The actual device was not returned and could not be investigated.In according to our investigation results based on dhr review and interview, we assumed that the cause of this event occurred due to the patient's condition and/or procedure.However, the damage occurred to concerned second i-ed coil might lead the partially protrude of the first implanted i-ed coil and additional coil implantation was required.In the instructions for use of i-ed coil (2376-1) , we state the potential of known risk as below; [precautions] 3.If any resistance is felt while advancing the pusher in the sheath or in the microcatheter, do not advance it forcibly.Identify the cause of resistance and remove the i-ed coil together with the microcatheter, if necessary, out of the patient.11.If the microcatheter kicks back from the position when performing embolization with a coil, do not attempt repositioning the microcatheter.If a repositioning is absolutely necessary, do it with a special care.Re-manipulation may cause migration of any placed coil into the peripheral blood vessel.[device failures, adverse events and complications] the following device failures, adverse events and complications may occur during the use of the i-ed coil.However, device failures, adverse events and complications are not limited to those listed below.Immediately take appropriate measures in the event that any abnormality occurs.1.Device failures (1) migration of the platinum coil (2) breakage or unraveling of the platinum coil (4) delivery failure of the platinum coil.
Event or Problem Description
Balloon assisted coil embolization of an left ica (internal carotid artery) aneurysm, diameter of 6mm width x 4mm height x 5mm depth.After delivery of a balloon catheter (transform super compliant 4mm x 10cm), placed in the vessel past the aneurysm for support during the procedure, an sl10 straight tip microcatheter for coil delivery was placed into the aneurysm.An i-ed coil complex soft (392-0620), lot# kr033037 was delivered through the microcatheter and placed into the aneurysm with assist from the balloon catheter to deliver the coil into place.The coil was detached and implanted without problem.The concerned i-ed coil 14 extrasoft (373-040815) was selected as the second coil and delivered through the microcatheter.The first half of the coil was delivered without problem but from there the physician experienced challenges in delivering the remainder of the coil as some resistance was met and the microcatheter was kicked out of the aneurysm as the coil herniated out.The balloon catheter was inflated a number of times in effort to keep the coil in the aneurysm but could not.After several attempt of pulling back and redelivery of the coil, stretching of the coil was confirmed.After attempting for approximately 30 minutes to deliver the coil, it was deemed the coil would not fit and was retrieved.During the retrieval of the coil, the coil broke off from the delivery wire, being left stuck in the microcatheter and partially in the aneurysm.The microcatheter with the coil stuck inside was pulled out be retrieved.During this process the position of the first implanted i-ed coil (392-0620) was partially disrupted and the end of the coil came dislodged.After removal of the concerned i-ed coil 14 extrasoft (373-040815), five stryker target coils were implanted to complete the treatment.The part of the first implanted i-ed coil (392-0620) that protruded out from the aneurysm was anchored to some extent by implanting the 5 stryker target coils.The patient woke up without problem after the procedure and no harm to the patient was confirmed.

• Brand Name: I-ED COIL SYSTEM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA MEDIX CORPORATION KANAGAWA PLANT; 225-1; aza deguchi; ashigara-kami-gun yamakita, kanagawa 258-0 113; JA 258-0113
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 18531822
• Report Number: 3009761573-2024-00001
• Device Sequence Number: 7697911
• Product Code: HCG
• UDI-Device Identifier: 04540778177635
• UDI-Public: 04540778177635
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

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: 373-040815
• Device Lot Number: KR013137
• 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: 01/09/2024
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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: IED-COIL COMPLEX SOFT (392-0620), LOT# KR033037
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female