MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL 5 MM X 15 CM HELICAL COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 7310-0515

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2023

Event Type  Injury  

Event Description

Attempts to place a hydrofill 5 mm x15 cm coil were unsuccessful as the coil detached prior to being fully deployed within the aneurysm and extended into the distal v3 segment of the left vertebral artery.The coil had to be removed from the body with a 2 mm amplatz gooseneck snare and progreat catheter using fluoroscopic guidance.Control angiography demonstrated progressive occlusion of the aneurysm.Completion angiography was performed in the working projection and ap(anterior-posterior) and lateral projections demonstrating no evidence for thrombus at the coil-parent artery interface or distal emboli.Catheter and sheath were removed from both the right and left common femoral artery access and hemostasis was obtained with an angio-seal device.Unintended coil detachment resulted in foreign body placement within the left vertebral artery requiring foreign body retrieval using amplatz gooseneck snare described above.

• Brand Name: HYDROFILL 5 MM X 15 CM HELICAL COIL
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; aliso viejo CA 92656
• MDR Report Key: 16743444
• MDR Text Key: 313412734
• Report Number: MW5116633
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 7310-0515
• Device Catalogue Number: 7310-0515
• Device Lot Number: 0000147155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZ GOOSENECK SNARE; ANGIO-SEAL; PROGREAT CATHETER; SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White