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

Model Number	UNKNOWN
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 coil remains implanted in the patient and the remainder of 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 vessel perforation, aneurysm rupture, and coil migration or misplacement as potential complications associated with use of the device.
Event or Problem Description
It was reported that balloon-assisted coil embolization was performed for a ruptured right posterior communicating artery aneurysm on a patient enrolled in a clinical trial.After the balloon had been inflated in the internal carotid artery (ica), two coil loops of the first coil herniated out of the aneurysm dome into the subarachnoid space.Two additional coils were subsequently placed with the balloon inflated.A contrast injection in the ica after deflation of the balloon demonstrated no extravasation and a follow-up ct performed post-procedure showed no evidence of hemorrhage.The patient was discharged home with minimal residual deficit from the initial (pre-treatment) hemorrhage following a 10-day stay in the hospital.

• Brand Name: HYDROFRAME
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8320707
• Report Number: 2032493-2019-00021
• Device Sequence Number: 19422576
• Product Code: HCG
• UDI-Device Identifier: 00810170018329
• UDI-Public: (01)00810170018329(11)180207(17)230131(10)1802075W3
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: UNKNOWN
• Device Catalogue Number: 45-780724
• Device Lot Number: 1810105WF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 77