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

Catalog Number 390-0204

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 09/02/2023

Event Type  Injury  

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, 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.Adverse events, injury to blood vessels or tissues, vessel wall dissection, blood vessel perforation, blood vessel rupture, bleeding, ischemia, stroke, cerebral infarction.Mfr report #: 3009761573-2023-00003.

Event Description

1st coil in the ica was implanted and during the deployment of the last 1cm of the 2x4 ss, the aneurysm ruptured.Noted a new catheter(headway (17) was used before the coil was deployed and no mention from the md that the coil was at fault.The same 2x4 ss was implanted three times prior with no incident with a 156 headway duo.Each of the three 1st attempts the last portion of the coil kicked out the 156 headway duo out of the aneurysm.The rupture occurred with the 4th attempt with the same 2x4 ss and the 1st time using the headway 17 catheter.One additional coil was placed, and the aneurysm was occluded.Patient was stable after another coil was given and coiling was complete.Manufacturer report # 3009761573-2023-00003.

• Brand Name: I-ED COIL SYSTEM
• Type of Device: 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: 17754331
• MDR Text Key: 323471354
• Report Number: 2435151-2023-00002
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04540778176515
• UDI-Public: 04540778176515
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 390-0204
• Device Lot Number: KR033129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female