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

Model 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	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Treatment of left mca bifurcation aneurysm, previous treated a year ago by stent assisted coiling using a "stryker neuroform atlas stent".Space to be coiled was 3.5mm x 2.5mm in size, behind the previously placed stent."stryker excelsior sl10" microcatheter selected for coil delivery.Microcatheter tip was placed into aneurysm through the stent struts.1st coil selected was the "ied coil complex infini silkysoft (393-020306)", delivered into the aneurysm without complications and deployed.2nd coil selected was the "ied coil complex silkysoft (390-01h3)", delivered into the aneurysm and positioned ready for deployment.During a visual check before deployment, rupture of the aneurysm and corresponding hemorrhage and coil loops outside of the aneurysm wall into the subdural space confirmed.Cause of rupture could not be identified but not directly related to coil.After hemorrhage was confirmed a further 8 ied coils were deployed into the space to stop the bleeding.Hemostasis was achieved approximately 27minutes after rupture of aneurysm.After procedure an hematoma approximately 3cm wide in size was confirmed at the point of rupture and patient was in an unstable condition.On 5/23/2023 additional information: patient was safely extubated, intact and in a stable condition.
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, 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.

• 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: 17045876
• Report Number: 3009761573-2023-00001
• Device Sequence Number: 20976671
• Product Code: HCG
• UDI-Device Identifier: 04540778176478
• UDI-Public: 04540778176478
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K192068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/23/2023

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: 05/31/2025
• Device Model Number: 390-01H3
• Device Catalogue Number: 39001H3
• Device Lot Number: KR013189
• 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: 05/23/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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: 70 YR
• Patient Sex: Female