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

Model Number	373-040815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned.Because it has been implanted in the patient's body.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 test.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.Doctor's comment: in a difficult case with using a stent, there was considerable resistance to the feel just before perforation, but when it was inserted as it was, the aneurysm was broken.The coil itself was moving well according to the concept and there was no malfunction.Our view: the facility has not reported any defects in the product, and we determine that it is due to the patient's condition and usage.However, since health hazards to patients (perforation and hemorrhagic cerebrovascular accidents) have occurred and have not been recovered, and the causal relationship between health hazards and the product cannot be completely ruled out, we will submit mdr (30 days).The following is stated in the ifu to call attention.[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
Coil embolization of waiting cases of internal carotid artery c2 and unruptured aneurysm.After the assist stent was placed, the product was used as the first framing from the microcatheter through the stent strut.The 3 cm to 4 cm part at the rear end of the coil did not fold well and the loop came out of the stent.While manipulating the catheter to correct it, the coil pierced the area near the bleb at the tip of the aneurysm.The product was left in place as it was, but the coil extended into the subarachnoid space.While expanding the balloon catheter near the aneurysm to stop bleeding, another 6 coils were placed for the purpose of stopping bleeding, but the bleeding did not stop easily.Protamine was administered, and finally hemostasis was maintained for about 1 hour.Although the patient's blood pressure was low, the amount of bleeding was large, so external ventricular drain was performed as it was.After drainage, a slight reduction in the pupil was confirmed, but severe disturbance of consciousness remained and he was hospitalized for follow-up.

• 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, 23082 88; JA 2308288
• MDR Report Key: 10640576
• Report Number: 3009761573-2020-00019
• Device Sequence Number: 2630800
• Product Code: HCG
• UDI-Device Identifier: 04540778177635
• UDI-Public: 04540778177635
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: 06/30/2023
• Device Model Number: 373-040815
• Device Catalogue Number: 373-040815
• Device Lot Number: KR070107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/07/2020
• 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: Disability
• Patient Age: 76 YR