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

Catalog Number	390-01H3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, and we determine that it was due to the patient's condition and procedure.However, since health hazards to the patient (rupture of aneurysm and consiquent additional operation) 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 (mfr repot# 3009761573-2024-00002).
Event or Problem Description
Case was 3.39mm wide anterior communicating artery unruptured aneurysm.First coil was successfully deployed which was a 3x4 complex extra soft coil.The second coil was deployed and about to detach in the aneurysm which was a 1.5 x 3 silk soft.The catheter kicked out if the aneurysm and the coil was removed and set aside.No issue at that time.The aneurysm was then reentered with a 156cm headway duo and additional support from the.038 dac moving distally.When entering the aneurysm the catheter did move the original coil and then we started to deploy the second coil.The coil was outside the aneurysm and the md thought it was the coil that caused the rupture/bleed.The second coil remained in the patient and the md thought it was enough coil to protect the now ruptured aneurysm.Unfortunately, the patient has some subarachnoid hemorrhage (sah) / intraventricular hemorrhage (ivh) and went for external ventricular drain (evd).Patient was given medication.

• 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, osaka 530-8 288,; JA 530-8288,
• MDR Report Key: 19464079
• Report Number: 2435151-2024-00002
• Device Sequence Number: 20826395
• Product Code: HCG
• UDI-Device Identifier: 04540778176478
• UDI-Public: (01)04540778176478(17)260831(10)KR093142
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2024
• Report Date (Section F): 06/03/2024

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: 08/31/2026
• Device Catalogue Number: 390-01H3
• Device Lot Number: KR093142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/07/2024
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/03/2024