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

Model Number	392-0410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Thrombosis/Thrombus (4440)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
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.We assume the cause of this as follows: the facility has not reported any defects in the product.We determine that it was due to the procedure and/or patient's condition.Since the concomitantly used microcatheter was withdrawn while the coils were not stable into the aneurysm, which caused coil was out and consequent health hazard.However, since health hazards to the patient (thrombosis and hemiplegia) occurred and have not recovered, and the causal relationship between health hazards and the product cannot be completely ruled out, we will submit mdr (30 days).In the instructions for use of i-ed coil (2376-1) , we state the potential of known risk as below; [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.2.Adverse events.(3) injury to blood vessels or tissues, vessel wall dissection, blood vessel perforation, blood vessel rupture.(5) bleeding, ischemia.(7) stroke, cerebral infarction.
Event or Problem Description
An aneurysm located in the anterior cerebral artery (a2) under mri; coils treatment.2 coil circles pull out of the aneurysm during the return microcatheter process resulting in thrombosis in these coil circles in the vessel.Anterior cerebral artery occlusion leads to hemiplegia.The coils were not stable into the aneurysm during the coiling process.Therefore, the coils were sucked out by the suction of the microcatheter when the microcatheter was pulled out.On june 1, 2023 additional information: now the patient has regained consciousness.

• 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: 17102941
• Report Number: 3009761573-2023-00002
• Device Sequence Number: 14995710
• Product Code: HCG
• UDI-Device Identifier: 04540778177048
• UDI-Public: 04540778177048
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K192068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 392-0410
• Device Catalogue Number: 392-0410
• Device Lot Number: KR013067
• 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: 05/31/2023
• Initial Report FDA Received Date: 06/12/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 60 KG