MAUDE Adverse Event Report: MICROVENTION INC. AZUR DETACHABLE HELICAL HYDROCOIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 45-450820

Device Problem Separation Failure (2547)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908)

Event Date 02/16/2016

Event Type  malfunction  

Event Description

Clinical history: over one year ago, with gated perfusion of thoracic false lumen from left subclavian artery down to termination of the dissection just below the celiac trunk.Recently admitted with ct showing growth of false lumen and chest pain associated with uncontrolled hypertension.The patient is status post left common carotid to left subclavian artery bypass and presents for left subclavian arteriogram, transcatheter embolization of left subclavian artery trunk and proximal communication with aortic false lumen.During the procedure washout in the left vertebral artery is antegrade, as would be expected following carotid subclavian bypass.Azur coils were prepared by playing them in a jet stream, allowing them to curl tightly.Multiple azur coils were then deposited in the proximal aortic false lumen in proximal left subclavian artery trunk and packed tightly.A 8mm x 15 cm azur coil was prepped in the manner described and placed for detachment.It was found that after several attempts the coil would not detach.The coil was removed and saved for investigation.The case continued without injury to the patient.

• Brand Name: AZUR DETACHABLE HELICAL HYDROCOIL
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6692597
• MDR Text Key: 79256311
• Report Number: 6692597
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 45-450820
• Device Catalogue Number: 45-450820
• Device Lot Number: 14100112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR