MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME; EMBOLIZATION COIL

Model Number UNKNOWN

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

Patient Problems Death (1802); Perforation of Vessels (2135); Rupture (2208)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown the instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with use of the device.

Event Description

It was reported that treatment was performed on a ruptured right internal carotid aneurysm.During insertion of the first coil, the coil ruptured the aneurysm sac, likely through the initial bleeding site.Protamine was given and onyx injected, which stopped the bleeding.A right frontal ventricular drain (evd) was placed to relieve intracranial pressure.The patient was noted to have fixed and dilated pupils at the time; however, the patient woke up with no neurological deficit and was given 500mg aspirin iv after the procedure.The patient is reported to still be in recovery.

Manufacturer Narrative

Additional information received: medical records and procedure operative report were received from the clinical research facility, which confirmed that the patient died on (b)(6) 2019 due to "brain death.".

• Brand Name: HYDROFRAME
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8423213
• MDR Text Key: 138893300
• Report Number: 2032493-2019-00046
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: UNKNOWN
• Device Lot Number: 1810015WF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 50 YR