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

Catalog Number	390-0101
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Paralysis (1997)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records (dhr -batch record) could not be investigated because the lot number is unknown.Every production lot passed all in-process inspections and finished product inspections before shipment.We assume the cause of this event as follows: the facility has not reported any defects in the product, and we determine that it was due to the patient's condition and procedure.However, since migration of several coils caused health hazards to the patient and additional devices were required during the procedure, and the causal relationship between health hazards and the product cannot be completely ruled out, we judged the case is reportable.In the instructions for use of i-ed coil (2376-1) , we state the potential of known risk as below; [precautions] 6.The size and number of coils to be placed should be carefully determined based on the experience of the physician.[operation methods] precautions 3.When placing a coil for finishing, carefully confirm the conditions of embolization and placement.If the size of the coil chosen is much smaller than the residual space-volume or the coil is not properly deployed in the basket that has been produced, the coil may migrate into the peripheral blood vessel when retrieving the microcatheter.[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.Adverse events, (4) embolization, (7) stroke, cerebral infarction, (8) nerve disorder.
Event or Problem Description
We, manufacturer kaneka, found this report as study literature survey, title: a case of successful retrieval using a stent retriever for coil migration during parent artery occlusion, journal: cjc open, 2024.[abstract]: coil migration during cerebral aneurysm embolization is uncommon but poses significant technical challenges.We report a 58-year-old woman with subarachnoid hemorrhage caused by a small dissecting aneurysm of the distal vertebral artery, located beyond the origin of the posterior inferior cerebellar artery (pica).Parent artery occlusion was performed.After completion of coil embolization, several finishing coils migrated into the pica during microcatheter withdrawal.A microcatheter was navigated into the pica, a stent retriever was deployed, and the migrated coils were captured between the stent retriever and microcatheter and removed en bloc.While a snare catheter is generally the first-line option for distal coil retrieval, a stent retriever can be an effective alternative when a microcatheter can be advanced into small or tortuous vessels.15 i-ed coils in total were placed in the anuerysm, but while withdrawing the concomitantly used microcatheter, several i-ed coils size in 1x1 for finishing were migrated into pica.The coil block was successfully removed by using a stent retriever.After 3 days of the operation, acute infarction was observed in the left cerebellar hemisphere, corresponding to the peripheral pica, but the postoperative was favorable, and the patient was transferred to a rehabilitation facility for mrs1 (abducens nerve palsy).

• Brand Name: I-ED COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE AND VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 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: akihiro tahara ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 24659660
• Report Number: 3009761573-2026-00001
• Device Sequence Number: 17413200
• Product Code: HCG
• UDI-Device Identifier: 04540778176423
• UDI-Public: 04540778176423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 390-0101
• 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: 02/05/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian